A Phase 3 interventional study of Dalbavancin and Vancomycin in Methicillin-Resistant Staphylococcus Aureus, Bacterial Infections and Staphylococcal Skin Infections, sponsored by AbbVie. Completed at 84 sites in 20 countries. Open to participants aged 0 Years to 17 Years. Per ClinicalTrials.gov, last updated 2024-09-19.
Sponsored by AbbVie · Phase 3, Interventional, and Treatment
To determine the safety and descriptive efficacy of dalbavancin for the treatment of acute bacterial skin and skin structure infections in children, aged birth to 17 years (inclusive), known or suspected to be caused by susceptible Gram-positive organisms, including methicillin-resistant strains of Staphylococcus aureus.
30 studies on the registry are indexed under Staphylococcal Skin Infections; none are open to participants now.
This study's enrollment of 199 is below the median of 227 across 28 interventional studies indexed under Staphylococcal Skin Infections.
Browse Staphylococcal Skin Infections studies →AbbVie is the lead sponsor of 973 studies on the registry; 133 are open to participants now.
Of its 357 completed or terminated interventional studies of FDA-regulated products, 214 (60%) have results posted.
Compared within Staphylococcal Skin Infections, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Bacterial Infections. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Major cutaneous abscess characterized as a collection of pus within the dermis or deeper that is accompanied by erythema, edema and/or induration which i. requires surgical incision and drainage, and ii. is associated with cellulitis such that the total affected area involves at least 35 cm2 of erythema, or total affected area of erythema is at least BSA (m2) x 43.0 (cm2/m2), OR iii. alternatively, involves the central face and is associated with an area of erythema of at least 15 cm2 b. Surgical site or traumatic wound infection characterized by purulent drainage with surrounding erythema, edema and/or induration which occurred within 30 days after the trauma or surgery and is associated with cellulitis such that: i. the total affected area involves at least 35 cm2 of erythema, or total affected area of erythema is at least BSA (m2) x 43.0 (cm2/m2), OR ii. alternatively, involves the central face and is associated with an affected area of at least 15 cm2 c. Cellulitis, defined as a diffuse skin infection characterized by spreading areas of erythema, edema and/or induration and: i. is associated with erythema that involves at least 35 cm2 of surface area, or surface area of erythema is at least BSA (m2) x 43.0 (cm2/m2), OR ii. alternatively, cellulitis of the central face that is associated with an affected area of at least 15 cm2 5. In addition to the requirement for erythema, all patients are required to have at least two (2) of the following signs of ABSSSI: a. Purulent drainage/discharge b. Fluctuance c. Heat/localized warmth d. Tenderness to palpation e. Swelling/induration
In patients age birth to \< 3 months, each patient must meet the following inclusion criteria to be enrolled in this study.
A clinical picture compatible with an ABSSSI suspected or confirmed to be caused by Gram-positive bacteria, including MRSA.
OR
Suspected or confirmed sepsis including any of the following clinical criteria:
In addition, patients must meet at least one of the following laboratory criteria:
a. White blood cell count ≤4.0 × 10\^9/L OR ≥20.0 × 10\^9/L b, Immature to total neutrophil ratio >0.2 c. count ≤100 × 10\^9/L d. C-reactive protein (CRP) >15 mg/L OR procalcitonin ≥ 2 ng/mL e. Hyperglycemia OR Hypoglycemia f. Metabolic acidosis
Infections must be of sufficient severity to merit hospitalization and parenteral antibiotic therapy. These infections may include:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
The number of CD4 cells, a type of white blood cell, in a given amount of blood. It is used to follow how well the immune system is doing in HIV.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CD4 count
The number of CD4 cells, a type of white blood cell, in a given amount of blood. It is used to follow how well the immune system is doing in HIV.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants received dalbavancin administered intravenously as follows: birth to \< 3 months old and 3 months to \< 6 years old: 22.5 mg/kg (maximum 1500 mg) on Day 1; ≥6 years to 17 years old (inclusive): 18 mg/kg (maximum 1500 mg) on Day 1. Participants aged birth to \< 3 months were not randomized; all received dalbavancin single-dose.
Drug: Dalbavancin
Participants received dalbavancin administered intravenously as follows: 3 months to \< 6 years old: 15 mg/kg (maximum 1000 mg) on Day 1, and 7.5 mg/kg (maximum 500 mg) on Day 8; ≥6 years to 17 years old (inclusive): 12 mg/kg (maximum 1000 mg) on Day 1, and 6 mg/kg (maximum 500 mg) on Day 8.
Drug: Dalbavancin
Participants 3 mos to \< 6 yrs old and ≥6 yrs to 17 yrs old received a 10-14 day course of either vancomycin 10 to 15 mg/kg/dose, not to exceed a 4000 mg total daily dose; or oxacillin 30 mg/kg/dose, infused over 60 (± 10) mins every 6 (± 1) hrs; or flucloxacillin 50 mg/kg/dose, infused over 60 (± 10) mins every 6 (± 1) hrs, not to exceed a 2000 mg total daily dose. Vancomycin was to be taken for methicillin-resistant Gram-positive infections. Based on local practice patterns/approvals for clinical use in the pediatric population, oxacillin or flucloxacillin were supplied as an IV comparator. At investigator's discretion, after 72 hrs of IV therapy, those on oxacillin or flucloxacillin could switch to oral cefadroxil (dose for infants/children: 15 mg/kg/dose every 12 hrs, max 2 g/day; dose for adolescents: 500-1000 mg every 12 hrs), and if infection with methicillin-resistant S. aureus was confirmed, those on vancomycin were allowed to switch to oral clindamycin 10 mg/kg every 8 hrs.
Drug: Vancomycin · Drug: Oxacillin · Drug: Flucloxacillin · Drug: Cefadroxil · Drug: Clindamycin
Dalbavancin was administered intravenously over 30 (± 5) minutes.
Also known as: Xydalba
Vancomycin was administered intravenously over 60 (± 10) minutes every 6 (± 1) hours.
Oxacillin was administered intravenously over 60 (± 10) minutes every 6 (± 1) hours.
Flucloxacillin was administered intravenously over 60 (± 10) minutes every 6 (± 1) hours.
Cefadroxil was administered orally every 12 hours.
Clindamycin was administered orally every 8 hours.
Shift From Baseline in Distortion Product Otoacoustic Emission at TOC Visit
Audiologic testing was to be conducted in at least 20 children \< 12 years old, of which at least 9 children were \< 2 years old. Audiologic testing conducted on infants (\< 12 months old) included: evoked otoacoustic emissions testing, acoustic immittance measures (tympanometry and contra and ipsilateral acoustic reflex thresholds) and (optional) threshold auditory brainstem responses. For the older children, testing included evoked otoacoustic emissions testing, acoustic immittance measures (tympanometry and contra ipsilateral acoustic reflex thresholds), and age appropriate behavioral audiologic threshold assessment. Participants with an abnormal audiologic assessment at Day 28 (± 2 days) that exceeded, by a clinically significant margin, any abnormality observed in the Baseline assessment, were considered to have an abnormal audiologic assessment.
Time frame: Baseline, Day 28 (± 2 days)
Shift From Baseline in Auditory Brainstem Response Test at TOC Visit
Audiologic testing was to be conducted in at least 20 children \< 12 years old, of which at least 9 children were \< 2 years old. Audiologic testing conducted on infants (\< 12 months old) included: evoked otoacoustic emissions testing, acoustic immittance measures (tympanometry and contra and ipsilateral acoustic reflex thresholds) and (optional) threshold auditory brainstem responses. For the older children, testing included evoked otoacoustic emissions testing, acoustic immittance measures (tympanometry and contra ipsilateral acoustic reflex thresholds), and age appropriate behavioral audiologic threshold assessment. Participants with an abnormal audiologic assessment at Day 28 (± 2 days) that exceeded, by a clinically significant margin, any abnormality observed in the Baseline assessment, were considered to have an abnormal audiologic assessment.
Time frame: Baseline, Day 28 (± 2 days)
Shift From Baseline in Acoustic Immittance Test at TOC Visit
Audiologic testing was to be conducted in at least 20 children \< 12 years old, of which at least 9 children were \< 2 years old. Audiologic testing conducted on infants (\< 12 months old) included: evoked otoacoustic emissions testing, acoustic immittance measures (tympanometry and contra and ipsilateral acoustic reflex thresholds) and (optional) threshold auditory brainstem responses. For the older children, testing included evoked otoacoustic emissions testing, acoustic immittance measures (tympanometry and contra ipsilateral acoustic reflex thresholds), and age appropriate behavioral audiologic threshold assessment. Participants with an abnormal audiologic assessment at Day 28 (± 2 days) that exceeded, by a clinically significant margin, any abnormality observed in the Baseline assessment, were considered to have an abnormal audiologic assessment.
Time frame: Baseline, Day 28 (± 2 days)
Shift From Baseline in Behavioral Audiometric Valuation at TOC Visit
Audiologic testing was to be conducted in at least 20 children \< 12 years old, of which at least 9 children were \< 2 years old. Audiologic testing conducted on infants (\< 12 months old) included: evoked otoacoustic emissions testing, acoustic immittance measures (tympanometry and contra and ipsilateral acoustic reflex thresholds) and (optional) threshold auditory brainstem responses. For the older children, testing included evoked otoacoustic emissions testing, acoustic immittance measures (tympanometry and contra ipsilateral acoustic reflex thresholds), and age appropriate behavioral audiologic threshold assessment. Participants with an abnormal audiologic assessment at Day 28 (± 2 days) that exceeded, by a clinically significant margin, any abnormality observed in the Baseline assessment, were considered to have an abnormal audiologic assessment.
Time frame: Baseline, Day 28 (± 2 days)
Shift From Baseline in Clostridium Difficile (CD) and Vancomycin-resistant Enterococci (VRE) at TOC Visit
Bowel flora was evaluated in participants from birth to \< 2 years of age by performing polymerase chain reaction (PCR) analysis for Clostridium difficile (C diff) and culture for vancomycin-resistant enterococci (VRE) on a stool specimen or rectal swab. Samples were analyzed at Baseline and at the Test of Cure (TOC) visit.
Time frame: Baseline, Day 28 (± 2 days)
Clinical Response at 48-72 Hours
Clinical response defined as ≥20% reduction in lesion size compared to Baseline in Cohorts 1-4; cessation of increase in lesion size and decreased erythema or tenderness compared to Baseline with no appearance of new lesions in those with ABSSSI in Cohort 5; and improvement of at least one abnormal clinical and laboratory parameter related to sepsis in those diagnosed with sepsis in Cohort 5. To be considered a clinical responder, participants must have been alive and not have received rescue therapy. Presented for the modified intent-to-treat (mITT) population: all participants who received at least one dose of study drug and had a diagnosis of ABSSSI (or a suspected or confirmed sepsis for those in Cohort 5) not known to be caused exclusively by a Gram-negative organism.
Time frame: Baseline, 48-72 hours
Clinical Response at the End of Treatment (EOT) Visit (Investigator Assessment of Clinical Outcome)
Cure: Resolution of clinical signs and symptoms of infection (CSSI) compared to Baseline. No additional antibacterial Tx required for disease under study. Improvement: For Cohorts 1-4 and Cohort 5 with ABSSSI, reduction in severity of ≥2, but not all CSSI, when compared with Baseline. For Cohort 5 with sepsis, reduction in severity of ≥1 abnormal clinical and laboratory parameter related to sepsis, when compared with Baseline. For Cohorts 1-4, no additional antibacterial Tx required for disease under study. For Cohort 5, no rescue antibiotics required after ≥48 hours of start of study Tx. Failure: Persistence or progression of Baseline CSSI after 48 hours of Tx OR development of new findings consistent with active infection. Unknown: Extenuating circumstances precluding classification to Cure, Improvement, or Failure. Presented for the modified intent-to-treat (mITT) population.
Time frame: Baseline, Day 14 (± 2 Days)
Clinical Response at the End of Treatment (EOT) Visit (Clinical Response by Sponsor)
Definitions used for the Sponsor assessment were the same as those used for the Investigator assessment. The occurrence of any of the following conditions resulted in reassignment by the Sponsor to clinical failure: 1) assessment of clinical failure at a previous time point, 2) Cohorts 1-4: receipt of concomitant antibiotic with activity against participant's isolate of disease under study prior to evaluation time point; Cohort 5: receipt of rescue therapy (additional antibiotic therapy initiated ≥48 hrs after study drug start), 3) unplanned surgical procedure (e.g., incision and drainage of abscess, major debridement, amputation) for non-improving or worsening infection after 72 hrs of study drug treatment. Presented for the modified intent-to-treat (mITT) population: all participants who received ≥1 dose of study drug and had a diagnosis of ABSSSI (or a suspected or confirmed sepsis for those in Cohort 5) not known to be caused exclusively by a Gram-negative organism.
Time frame: Baseline, Day 14 (± 2 Days)
Clinical Response at the Test of Cure (TOC) Visit (Investigator Assessment of Clinical Outcome)
Cure: Resolution of clinical signs and symptoms of infection (CSSI) compared to Baseline. No additional antibacterial Tx required for disease under study. Failure: Persistence or progression of Baseline CSSI after 48 hours of Tx OR development of new findings consistent with active infection. Unknown: Extenuating circumstances precluding classification to Cure or Failure. Presented for the modified intent-to-treat (mITT) population.
Time frame: Baseline, Day 28 (± 2 Days)
Clinical Response at the Test of Cure (TOC) Visit (Clinical Response by Sponsor)
Definitions used for the Sponsor assessment were the same as those used for the Investigator assessment. The occurrence of any of the following conditions resulted in reassignment by the Sponsor to clinical failure: 1) assessment of clinical failure at a previous time point, 2) Cohorts 1-4: receipt of concomitant antibiotic with activity against participant's isolate of disease under study prior to evaluation time point; Cohort 5: receipt of rescue therapy (additional antibiotic therapy initiated ≥48 hrs after study drug start), 3) unplanned surgical procedure (e.g., incision and drainage of abscess, major debridement, amputation) for non-improving or worsening infection after 72 hrs of study drug treatment. Presented for the modified intent-to-treat (mITT) population: all participants who received ≥1 dose of study drug and had a diagnosis of ABSSSI (or a suspected or confirmed sepsis for those in Cohort 5) not known to be caused exclusively by a Gram-negative organism.
Time frame: Baseline, Day 28 (± 2 Days)
Clinical Response at the Follow-Up Visit (Investigator Assessment of Clinical Outcome)
Cure: Resolution of clinical signs and symptoms of infection (CSSI) compared to Baseline. No additional antibacterial Tx required for disease under study. Failure: Persistence or progression of Baseline CSSI after 48 hours of Tx OR development of new findings consistent with active infection. Unknown: Extenuating circumstances precluding classification to Cure or Failure. Presented for the modified intent-to-treat (mITT) population
Time frame: Baseline, Day 54 (± 7 days)
Clinical Response at the Follow-Up Visit (Clinical Response by Sponsor)
Definitions used for the Sponsor assessment were the same as those used for the Investigator assessment. The occurrence of any of the following conditions resulted in reassignment by the Sponsor to clinical failure: 1) assessment of clinical failure at a previous time point, 2) Cohorts 1-4: receipt of concomitant antibiotic with activity against participant's isolate of disease under study prior to evaluation time point; Cohort 5: receipt of rescue therapy (additional antibiotic therapy initiated ≥48 hrs after study drug start), 3) unplanned surgical procedure (e.g., incision and drainage of abscess, major debridement, amputation) for non-improving or worsening infection after 72 hrs of study drug treatment. Presented for the modified intent-to-treat (mITT) population: all participants who received ≥1 dose of study drug and had a diagnosis of ABSSSI (or a suspected or confirmed sepsis for those in Cohort 5) not known to be caused exclusively by a Gram-negative organism.
Time frame: Baseline, Day 54 (± 7 days)
Clinical Response by Baseline Pathogen at 48-72 Hours (Clinical Response by Sponsor)
Clinical response defined as ≥20% reduction in lesion size compared to Baseline in Cohorts 1-4; cessation of increase in lesion size and decreased erythema or tenderness compared to Baseline with no appearance of new lesions in those with ABSSSI in Cohort 5; and improvement of at least one abnormal clinical and laboratory parameter related to sepsis in those diagnosed with sepsis in Cohort 5. To be considered a clinical responder, participants must have been alive and not have received rescue therapy. Presented for the microbiological intent-to-treat (microITT) population: all randomized (or enrolled in Cohort 5) participants who had at least 1 Gram-positive pathogen isolated at Baseline.
Time frame: Baseline, 48-72 hours
Clinical Response by Baseline Pathogen at the End of Treatment (EOT) Visit (Investigator Assessment of Clinical Outcome)
Cure: Resolution of clinical signs/symptoms of infection (CSSI) compared to Baseline. No additional antibacterial Tx required for disease under study. Improvement: Cohorts 1-4 and Cohort 5 with ABSSSI: reduction in severity of ≥2, but not all CSSI, when compared to Baseline. Cohort 5 with sepsis: reduction in severity of ≥1 abnormal clinical/laboratory parameter related to sepsis, when compared to Baseline. Cohorts 1-4: no additional antibacterial Tx required for disease under study. Cohort 5: no rescue antibiotics required after ≥48 hrs of start of study Tx. Failure: Persistence/progression of Baseline CSSI after 48 hrs of Tx OR development of new findings consistent with active infection. Unknown: Extenuating circumstances precluding classification to Cure, Improvement, or Failure. Presented for the microbiological intent-to-treat (microITT) population: all randomized (or enrolled in Cohort 5) participants who had at least 1 Gram-positive pathogen isolated at Baseline.
Time frame: Baseline, Day 14 (± 2 Days)
Clinical Response by Baseline Pathogen at the End of Treatment (EOT) Visit (Clinical Response by Sponsor)
Definitions used for the Sponsor assessment were the same as those used for the Investigator assessment. The occurrence of any of the following conditions resulted in reassignment by the Sponsor to clinical failure: 1) assessment of clinical failure at a previous time point, 2) Cohorts 1-4: receipt of concomitant antibiotic with activity against participant's isolate of disease under study prior to evaluation time point; Cohort 5: receipt of rescue therapy (additional antibiotic therapy initiated ≥48 hrs after study drug start), 3) unplanned surgical procedure (e.g., incision and drainage of abscess, major debridement, amputation) for non-improving or worsening infection after 72 hrs of study drug treatment. Presented for the microbiological intent-to-treat (microITT) population: all randomized (or enrolled in Cohort 5) participants who had at least 1 Gram-positive pathogen isolated at Baseline.
Time frame: Baseline, Day 14 (± 2 Days)
Clinical Response by Baseline Pathogen at the Test of Cure (TOC) Visit (Investigator Assessment of Clinical Outcome)
Cure: Resolution of clinical signs and symptoms of infection (CSSI) compared to Baseline. No additional antibacterial Tx required for disease under study. Failure: Persistence or progression of Baseline CSSI after 48 hours of Tx OR development of new findings consistent with active infection. Unknown: Extenuating circumstances precluding classification to Cure or Failure. Presented for the microbiological intent-to-treat (microITT) population: all randomized (or enrolled in Cohort 5) participants who had at least 1 Gram-positive pathogen isolated at Baseline.
Time frame: Baseline, Day 28 (± 2 Days)
Clinical Response by Baseline Pathogen at the Test of Cure (TOC) Visit (Clinical Response by Sponsor)
Definitions used for the Sponsor assessment were the same as those used for the Investigator assessment. The occurrence of any of the following conditions resulted in reassignment by the Sponsor to clinical failure: 1) assessment of clinical failure at a previous time point, 2) Cohorts 1-4: receipt of concomitant antibiotic with activity against participant's isolate of disease under study prior to evaluation time point; Cohort 5: receipt of rescue therapy (additional antibiotic therapy initiated ≥48 hrs after study drug start), 3) unplanned surgical procedure (e.g., incision and drainage of abscess, major debridement, amputation) for non-improving or worsening infection after 72 hrs of study drug treatment. Presented for the microbiological intent-to-treat (microITT) population: all randomized (or enrolled in Cohort 5) participants who had at least 1 Gram-positive pathogen isolated at Baseline.
Time frame: Baseline, Day 28 (± 2 Days)
Clinical Response by Baseline Pathogen at the Follow-up Visit (Investigator Assessment of Clinical Outcome)
Cure: Resolution of clinical signs and symptoms of infection (CSSI) compared to Baseline. No additional antibacterial Tx required for disease under study. Failure: Persistence or progression of Baseline CSSI after 48 hours of Tx OR development of new findings consistent with active infection. Unknown: Extenuating circumstances precluding classification to Cure or Failure. Presented for the microbiological intent-to-treat (microITT) population: all randomized (or enrolled in Cohort 5) participants who had at least 1 Gram-positive pathogen isolated at Baseline.
Time frame: Baseline, Day 54 (± 7 days)
Clinical Response by Baseline Pathogen at the Follow-up Visit (Clinical Response by Sponsor)
Definitions used for the Sponsor assessment were the same as those used for the Investigator assessment. The occurrence of any of the following conditions resulted in reassignment by the Sponsor to clinical failure: 1) assessment of clinical failure at a previous time point, 2) Cohorts 1-4: receipt of concomitant antibiotic with activity against participant's isolate of disease under study prior to evaluation time point; Cohort 5: receipt of rescue therapy (additional antibiotic therapy initiated ≥48 hrs after study drug start), 3) unplanned surgical procedure (e.g., incision and drainage of abscess, major debridement, amputation) for non-improving or worsening infection after 72 hrs of study drug treatment. Presented for the microbiological intent-to-treat (microITT) population: all randomized (or enrolled in Cohort 5) participants who had at least 1 Gram-positive pathogen isolated at Baseline.
Time frame: Baseline, Day 54 (± 7 days)
Microbiological Response at 48-72 Hours
Eradication: Source specimen demonstrated absence of the original Baseline pathogen. Presumed eradication: Source specimen was not available to culture and the participant was assessed as a clinical responder. Persistence: Source specimen demonstrated continued presence of the original Baseline pathogen. Presumed persistence: Source specimen was not available to culture and the participant was assessed as a clinical non-responder. Indeterminate: Source specimen was not available to culture and the participant's clinical response was unknown or missing. Presented for the microbiological intent-to-treat (microITT) population: all randomized (or enrolled in Cohort 5) participants who had at least 1 Gram-positive pathogen isolated at Baseline.
Time frame: Baseline, 48-72 hours
Microbiological Response at the End of Treatment (EOT) Visit
Eradication: Source specimen demonstrated absence of the original Baseline pathogen. Presumed eradication: Source specimen was not available to culture and the participant was assessed as a clinical cure or improvement. Persistence: Source specimen demonstrated continued presence of the original Baseline pathogen. Presumed persistence: Source specimen was not available to culture and the participant was assessed as a clinical failure. Indeterminate: Source specimen was not available to culture and the participant's clinical response was unknown or missing. Presented for the microbiological intent-to-treat (microITT) population: all randomized (or enrolled in Cohort 5) participants who had at least 1 Gram-positive pathogen isolated at Baseline.
Time frame: Baseline, Day 14 (± 2 Days)
Microbiological Response at the Test of Cure (TOC) Visit
Eradication: Source specimen demonstrated absence of the original Baseline pathogen. Presumed eradication: Source specimen was not available to culture and the participant was assessed as a clinical cure. Persistence: Source specimen demonstrated continued presence of the original Baseline pathogen. Presumed persistence: Source specimen was not available to culture and the participant was assessed as a clinical failure. Indeterminate: Source specimen was not available to culture and the participant's clinical response was unknown or missing. Presented for the microbiological intent-to-treat (microITT) population: all randomized (or enrolled in Cohort 5) participants who had at least 1 Gram-positive pathogen isolated at Baseline.
Time frame: Baseline, Day 28 (± 2 Days)
Microbiological Response at the Follow-Up Visit
Eradication: Source specimen demonstrated absence of the original Baseline pathogen. Presumed eradication: Source specimen was not available to culture and the participant was assessed as a clinical cure. Persistence: Source specimen demonstrated continued presence of the original Baseline pathogen. Presumed persistence: Source specimen was not available to culture and the participant was assessed as a clinical failure. Indeterminate: Source specimen was not available to culture and the participant's clinical response was unknown or missing. Presented for the microbiological intent-to-treat (microITT) population: all randomized (or enrolled in Cohort 5) participants who had at least 1 Gram-positive pathogen isolated at Baseline.
Time frame: Baseline, Day 54 (± 7 days)
Microbiological Response at 48-72 Hours by Baseline Gram-positive Pathogen
Eradication: Source specimen demonstrated absence of the original Baseline pathogen. Presumed eradication: Source specimen was not available to culture and the participant was assessed as a clinical responder. Persistence: Source specimen demonstrated continued presence of the original Baseline pathogen. Presumed persistence: Source specimen was not available to culture and the participant was assessed as a clinical non-responder. Indeterminate: Source specimen was not available to culture and the participant's clinical response was unknown or missing., Presented for the microbiological intent-to-treat (microITT) population: all randomized (or enrolled in Cohort 5) participants who had at least 1 Gram-positive pathogen isolated at Baseline.
Time frame: Baseline, 48-72 hours
Microbiological Response at the End of Treatment (EOT) Visit by Baseline Gram-positive Pathogen
Eradication: Source specimen demonstrated absence of the original Baseline pathogen. Presumed eradication: Source specimen was not available to culture and the participant was assessed as a clinical cure or improvement. Persistence: Source specimen demonstrated continued presence of the original Baseline pathogen. Presumed persistence: Source specimen was not available to culture and the participant was assessed as a clinical failure. Indeterminate: Source specimen was not available to culture and the participant's clinical response was unknown or missing. Presented for the microbiological intent-to-treat (microITT) population: all randomized (or enrolled in Cohort 5) participants who had at least 1 Gram-positive pathogen isolated at Baseline.
Time frame: Baseline, Day 14 (± 2 Days)
Microbiological Response at the Test of Cure (TOC) Visit by Baseline Gram-positive Pathogen
Eradication: Source specimen demonstrated absence of the original Baseline pathogen. Presumed eradication: Source specimen was not available to culture and the participant was assessed as a clinical cure. Persistence: Source specimen demonstrated continued presence of the original Baseline pathogen. Presumed persistence: Source specimen was not available to culture and the participant was assessed as a clinical failure. Indeterminate: Source specimen was not available to culture and the participant's clinical response was unknown or missing. Presented for the microbiological intent-to-treat (microITT) population: all randomized (or enrolled in Cohort 5) participants who had at least 1 Gram-positive pathogen isolated at Baseline.
Time frame: Baseline, Day 28 (± 2 Days)
Microbiological Response at the Follow-Up Visit by Baseline Gram-positive Pathogen
Eradication: Source specimen demonstrated absence of the original Baseline pathogen. Presumed eradication: Source specimen was not available to culture and the participant was assessed as a clinical cure. Persistence: Source specimen demonstrated continued presence of the original Baseline pathogen. Presumed persistence: Source specimen was not available to culture and the participant was assessed as a clinical failure. Indeterminate: Source specimen was not available to culture and the participant's clinical response was unknown or missing. Presented for the microbiological intent-to-treat (microITT) population: all randomized (or enrolled in Cohort 5) participants who had at least 1 Gram-positive pathogen isolated at Baseline.
Time frame: Baseline, Day 54 (± 7 days)
All-cause Mortality at the Test of Cure (TOC) Visit Among Cohort 5 Participants
All-cause mortality was determined for the participants in Cohort 5 (birth to \< 3 months) at the Test of Cure visit.
Time frame: Day 28 (± 2 Days)
Concentration of Dalbavancin in Plasma
The population pharmacokinetic (PK) profile of dalbavancin was assessed using a sparse sampling approach. Plasma PK samples were collected from participants receiving dalbavancin treatment (single-dose and two-dose arms) at 30 minutes and at 2 hours (Day 1), at 48-72 hours (Day 3-4), at 168 ± 24 hours (Day 8 ± 1), and at 312 ± 48 hours and analyzed for dalbavancin concentration.
Time frame: 30 min (end of infusion on Day 1); 2 hrs after start of IV (Day 1); and 48-72 hrs, 168 hrs, and 312 hrs after start of IV
| Milestone | Dalbavancin Single-dose | Dalbavancin Two-dose | Comparator |
|---|---|---|---|
| Started | 91 | 78 | 30 |
| Completed | 91 | 74 | 30 |
| Not completed | 0 | 4 | 0 |
| Withdrew: Withdrawal of consent | 0 | 2 | 0 |
| Withdrew: Lost to follow-up | 0 | 1 | 0 |
| Withdrew: Other, not specified | 0 | 1 | 0 |
Audiologic testing was to be conducted in at least 20 children \< 12 years old, of which at least 9 children were \< 2 years old. Audiologic testing conducted on infants (\< 12 months old) included: evoked otoacoustic emissions testing, acoustic immittance measures (tympanometry and contra and ipsilateral acoustic reflex thresholds) and (optional) threshold auditory brainstem responses. For the older children, testing included evoked otoacoustic emissions testing, acoustic immittance measures (tympanometry and contra ipsilateral acoustic reflex thresholds), and age appropriate behavioral audiologic threshold assessment. Participants with an abnormal audiologic assessment at Day 28 (± 2 days) that exceeded, by a clinically significant margin, any abnormality observed in the Baseline assessment, were considered to have an abnormal audiologic assessment.
| Participants | Dalbavancin Single-dose | Dalbavancin Two-dose | Comparator |
|---|---|---|---|
| Baseline & TOC normal | 2 | — | 1 |
| Baseline normal & TOC abnormal | 0 | — | 0 |
| Baseline abnormal & TOC normal | 0 | — | 0 |
| Baseline & TOC abnormal | 0 | — | 0 |
Audiologic testing was to be conducted in at least 20 children \< 12 years old, of which at least 9 children were \< 2 years old. Audiologic testing conducted on infants (\< 12 months old) included: evoked otoacoustic emissions testing, acoustic immittance measures (tympanometry and contra and ipsilateral acoustic reflex thresholds) and (optional) threshold auditory brainstem responses. For the older children, testing included evoked otoacoustic emissions testing, acoustic immittance measures (tympanometry and contra ipsilateral acoustic reflex thresholds), and age appropriate behavioral audiologic threshold assessment. Participants with an abnormal audiologic assessment at Day 28 (± 2 days) that exceeded, by a clinically significant margin, any abnormality observed in the Baseline assessment, were considered to have an abnormal audiologic assessment.
| Participants | Dalbavancin Single-dose | Dalbavancin Two-dose | Comparator |
|---|---|---|---|
| Baseline & TOC normal | 1 | — | — |
| Baseline normal & TOC abnormal | 0 | — | — |
| Baseline abnormal & TOC normal | 0 | — | — |
| Baseline & TOC abnormal | 0 | — | — |
Audiologic testing was to be conducted in at least 20 children \< 12 years old, of which at least 9 children were \< 2 years old. Audiologic testing conducted on infants (\< 12 months old) included: evoked otoacoustic emissions testing, acoustic immittance measures (tympanometry and contra and ipsilateral acoustic reflex thresholds) and (optional) threshold auditory brainstem responses. For the older children, testing included evoked otoacoustic emissions testing, acoustic immittance measures (tympanometry and contra ipsilateral acoustic reflex thresholds), and age appropriate behavioral audiologic threshold assessment. Participants with an abnormal audiologic assessment at Day 28 (± 2 days) that exceeded, by a clinically significant margin, any abnormality observed in the Baseline assessment, were considered to have an abnormal audiologic assessment.
| Participants | Dalbavancin Single-dose | Dalbavancin Two-dose | Comparator |
|---|---|---|---|
| Baseline & TOC normal | 8 | 4 | 3 |
| Baseline normal & TOC abnormal | 0 | 0 | 0 |
| Baseline abnormal & TOC normal | 0 | 0 | 0 |
| Baseline & TOC abnormal | 0 | 0 | 0 |
Audiologic testing was to be conducted in at least 20 children \< 12 years old, of which at least 9 children were \< 2 years old. Audiologic testing conducted on infants (\< 12 months old) included: evoked otoacoustic emissions testing, acoustic immittance measures (tympanometry and contra and ipsilateral acoustic reflex thresholds) and (optional) threshold auditory brainstem responses. For the older children, testing included evoked otoacoustic emissions testing, acoustic immittance measures (tympanometry and contra ipsilateral acoustic reflex thresholds), and age appropriate behavioral audiologic threshold assessment. Participants with an abnormal audiologic assessment at Day 28 (± 2 days) that exceeded, by a clinically significant margin, any abnormality observed in the Baseline assessment, were considered to have an abnormal audiologic assessment.
| Participants | Dalbavancin Single-dose | Dalbavancin Two-dose | Comparator |
|---|---|---|---|
| Baseline & TOC normal | 8 | 5 | 4 |
| Baseline normal & TOC abnormal | 0 | 0 | 0 |
| Baseline abnormal & TOC normal | 0 | 0 | 0 |
| Baseline & TOC abnormal | 0 | 0 | 0 |
Bowel flora was evaluated in participants from birth to \< 2 years of age by performing polymerase chain reaction (PCR) analysis for Clostridium difficile (C diff) and culture for vancomycin-resistant enterococci (VRE) on a stool specimen or rectal swab. Samples were analyzed at Baseline and at the Test of Cure (TOC) visit.
| Participants | Dalbavancin Single-dose | Dalbavancin Two-dose | Comparator |
|---|---|---|---|
| C diff Baseline & TOC positive | 1 | 0 | 0 |
| C diff Baseline positive & TOC negative | 3 | 1 | 0 |
| C diff Baseline positive & TOC missing | 2 | 1 | 0 |
| C diff Baseline negative & TOC positive | 0 | 0 | 0 |
| C diff Baseline negative & TOC negative | 10 | 4 | 1 |
| C diff Baseline negative & TOC missing | 1 | 1 | 0 |
| C diff Baseline missing & TOC positive | 0 | 0 | 0 |
| C diff Baseline missing & TOC negative | 2 | 0 | 1 |
| C diff Baseline missing & TOC missing | 0 | 1 | 1 |
| VRE Baseline & TOC positive | 1 | 0 | 0 |
| VRE Baseline positive & TOC negative | 0 | 0 | 0 |
| VRE Baseline positive & TOC missing | 0 | 1 | 0 |
| VRE Baseline negative & TOC positive | 0 | 0 | 0 |
| VRE Baseline negative & TOC negative | 15 | 5 | 0 |
| VRE Baseline negative & TOC missing | 1 | 2 | 2 |
| VRE Baseline missing & TOC positive | 1 | 0 | 0 |
| VRE Baseline missing & TOC negative | 1 | 0 | 1 |
| VRE Baseline missing & TOC missing | 0 | 0 | 0 |
Clinical response defined as ≥20% reduction in lesion size compared to Baseline in Cohorts 1-4; cessation of increase in lesion size and decreased erythema or tenderness compared to Baseline with no appearance of new lesions in those with ABSSSI in Cohort 5; and improvement of at least one abnormal clinical and laboratory parameter related to sepsis in those diagnosed with sepsis in Cohort 5. To be considered a clinical responder, participants must have been alive and not have received rescue therapy. Presented for the modified intent-to-treat (mITT) population: all participants who received at least one dose of study drug and had a diagnosis of ABSSSI (or a suspected or confirmed sepsis for those in Cohort 5) not known to be caused exclusively by a Gram-negative organism.
| percentage of participants | Dalbavancin Single-dose | Dalbavancin Two-dose | Comparator |
|---|---|---|---|
| Clinical Responder | 96.5 | 98.6 | 89.7 |
| Clinical Non-Responder | 3.5 | 1.4 | 10.3 |
Cure: Resolution of clinical signs and symptoms of infection (CSSI) compared to Baseline. No additional antibacterial Tx required for disease under study. Improvement: For Cohorts 1-4 and Cohort 5 with ABSSSI, reduction in severity of ≥2, but not all CSSI, when compared with Baseline. For Cohort 5 with sepsis, reduction in severity of ≥1 abnormal clinical and laboratory parameter related to sepsis, when compared with Baseline. For Cohorts 1-4, no additional antibacterial Tx required for disease under study. For Cohort 5, no rescue antibiotics required after ≥48 hours of start of study Tx. Failure: Persistence or progression of Baseline CSSI after 48 hours of Tx OR development of new findings consistent with active infection. Unknown: Extenuating circumstances precluding classification to Cure, Improvement, or Failure. Presented for the modified intent-to-treat (mITT) population.
| percentage of participants | Dalbavancin Single-dose | Dalbavancin Two-dose | Comparator |
|---|---|---|---|
| Clinical Cure | 92.9 | 93.2 | 100 |
| Improvement | 6.0 | 5.5 | 0 |
| Clinical Failure | 1.2 | 1.4 | 0 |
| Unknown | 0 | 0 | 0 |
Definitions used for the Sponsor assessment were the same as those used for the Investigator assessment. The occurrence of any of the following conditions resulted in reassignment by the Sponsor to clinical failure: 1) assessment of clinical failure at a previous time point, 2) Cohorts 1-4: receipt of concomitant antibiotic with activity against participant's isolate of disease under study prior to evaluation time point; Cohort 5: receipt of rescue therapy (additional antibiotic therapy initiated ≥48 hrs after study drug start), 3) unplanned surgical procedure (e.g., incision and drainage of abscess, major debridement, amputation) for non-improving or worsening infection after 72 hrs of study drug treatment. Presented for the modified intent-to-treat (mITT) population: all participants who received ≥1 dose of study drug and had a diagnosis of ABSSSI (or a suspected or confirmed sepsis for those in Cohort 5) not known to be caused exclusively by a Gram-negative organism.
| percentage of participants | Dalbavancin Single-dose | Dalbavancin Two-dose | Comparator |
|---|---|---|---|
| Cure | 90.5 | 91.9 | 100 |
| Improvement | 7.1 | 5.4 | 0 |
| Failure | 2.4 | 2.7 | 0 |
| Unknown | 0 | 0 | 0 |
Cure: Resolution of clinical signs and symptoms of infection (CSSI) compared to Baseline. No additional antibacterial Tx required for disease under study. Failure: Persistence or progression of Baseline CSSI after 48 hours of Tx OR development of new findings consistent with active infection. Unknown: Extenuating circumstances precluding classification to Cure or Failure. Presented for the modified intent-to-treat (mITT) population.
| percentage of participants | Dalbavancin Single-dose | Dalbavancin Two-dose | Comparator |
|---|---|---|---|
| Clinical Cure | 98.8 | 98.6 | 100 |
| Clinical Failure | 1.2 | 1.4 | 0 |
| Unknown | 0 | 0 | 0 |
Definitions used for the Sponsor assessment were the same as those used for the Investigator assessment. The occurrence of any of the following conditions resulted in reassignment by the Sponsor to clinical failure: 1) assessment of clinical failure at a previous time point, 2) Cohorts 1-4: receipt of concomitant antibiotic with activity against participant's isolate of disease under study prior to evaluation time point; Cohort 5: receipt of rescue therapy (additional antibiotic therapy initiated ≥48 hrs after study drug start), 3) unplanned surgical procedure (e.g., incision and drainage of abscess, major debridement, amputation) for non-improving or worsening infection after 72 hrs of study drug treatment. Presented for the modified intent-to-treat (mITT) population: all participants who received ≥1 dose of study drug and had a diagnosis of ABSSSI (or a suspected or confirmed sepsis for those in Cohort 5) not known to be caused exclusively by a Gram-negative organism.
| percentage of participants | Dalbavancin Single-dose | Dalbavancin Two-dose | Comparator |
|---|---|---|---|
| Cure | 95.2 | 97.3 | 100 |
| Failure | 2.4 | 2.7 | 0 |
| Unknown | 2.4 | 0 | 0 |
Cure: Resolution of clinical signs and symptoms of infection (CSSI) compared to Baseline. No additional antibacterial Tx required for disease under study. Failure: Persistence or progression of Baseline CSSI after 48 hours of Tx OR development of new findings consistent with active infection. Unknown: Extenuating circumstances precluding classification to Cure or Failure. Presented for the modified intent-to-treat (mITT) population
| percentage of participants | Dalbavancin Single-dose | Dalbavancin Two-dose | Comparator |
|---|---|---|---|
| Clinical Cure | 97.6 | 97.3 | 100 |
| Clinical Failure | 1.2 | 1.4 | 0 |
| Unknown | 1.2 | 1.4 | 0 |
Definitions used for the Sponsor assessment were the same as those used for the Investigator assessment. The occurrence of any of the following conditions resulted in reassignment by the Sponsor to clinical failure: 1) assessment of clinical failure at a previous time point, 2) Cohorts 1-4: receipt of concomitant antibiotic with activity against participant's isolate of disease under study prior to evaluation time point; Cohort 5: receipt of rescue therapy (additional antibiotic therapy initiated ≥48 hrs after study drug start), 3) unplanned surgical procedure (e.g., incision and drainage of abscess, major debridement, amputation) for non-improving or worsening infection after 72 hrs of study drug treatment. Presented for the modified intent-to-treat (mITT) population: all participants who received ≥1 dose of study drug and had a diagnosis of ABSSSI (or a suspected or confirmed sepsis for those in Cohort 5) not known to be caused exclusively by a Gram-negative organism.
| percentage of participants | Dalbavancin Single-dose | Dalbavancin Two-dose | Comparator |
|---|---|---|---|
| Cure | 96.4 | 97.3 | 100 |
| Failure | 2.4 | 2.7 | 0 |
| Unknown | 1.2 | 0 | 0 |
Clinical response defined as ≥20% reduction in lesion size compared to Baseline in Cohorts 1-4; cessation of increase in lesion size and decreased erythema or tenderness compared to Baseline with no appearance of new lesions in those with ABSSSI in Cohort 5; and improvement of at least one abnormal clinical and laboratory parameter related to sepsis in those diagnosed with sepsis in Cohort 5. To be considered a clinical responder, participants must have been alive and not have received rescue therapy. Presented for the microbiological intent-to-treat (microITT) population: all randomized (or enrolled in Cohort 5) participants who had at least 1 Gram-positive pathogen isolated at Baseline.
| percentage of participants | Dalbavancin Single-dose | Dalbavancin Two-dose | Comparator |
|---|---|---|---|
| S. aureus (MRSA),Clinical Responder | 100 | 100 | — |
| S. aureus (MRSA),Clinical Non-Responder | 0 | 0 | — |
| S. aureus (MSSA),Clinical Responder | 97.9 | 95.5 | 85.7 |
| S. aureus (MSSA),Clinical Non-Responder | 2.1 | 2.3 | 7.1 |
| S. aureus (MSSA),Missing | 0 | 2.3 | 7.1 |
| S. agalactiae, Clinical Responder | — | 100 | — |
| S. agalactiae, Clinical Non-Responder | — | 0 | — |
| S. anginosus, Clinical Responder | 100 | — | — |
| S. anginosus, Clinical Non-Responder | 0 | — | — |
| S. constellatus, Clinical Responder | — | 100 | — |
| S. constellatus, Clinical Non-Responder | — | 0 | — |
| S. intermedius, Clinical Responder | — | 100 | — |
| S. intermedius, Clinical Non-Responder | — | 0 | — |
| S. pyogenes, Clinical Responder | 80 | 75 | 100 |
| S. pyogenes, Clinical Non-Responder | 20 | 0 | 0 |
| S. pyogenes, Missing | 0 | 25 | 0 |
| E. faecalis, Clinical Responder | 100 | 100 | — |
| E. faecalis, Clinical Non-Responder | 0 | 0 | — |
Cure: Resolution of clinical signs/symptoms of infection (CSSI) compared to Baseline. No additional antibacterial Tx required for disease under study. Improvement: Cohorts 1-4 and Cohort 5 with ABSSSI: reduction in severity of ≥2, but not all CSSI, when compared to Baseline. Cohort 5 with sepsis: reduction in severity of ≥1 abnormal clinical/laboratory parameter related to sepsis, when compared to Baseline. Cohorts 1-4: no additional antibacterial Tx required for disease under study. Cohort 5: no rescue antibiotics required after ≥48 hrs of start of study Tx. Failure: Persistence/progression of Baseline CSSI after 48 hrs of Tx OR development of new findings consistent with active infection. Unknown: Extenuating circumstances precluding classification to Cure, Improvement, or Failure. Presented for the microbiological intent-to-treat (microITT) population: all randomized (or enrolled in Cohort 5) participants who had at least 1 Gram-positive pathogen isolated at Baseline.
| percentage of participants | Dalbavancin Single-dose | Dalbavancin Two-dose | Comparator |
|---|---|---|---|
| S. aureus (MRSA),Clinical Cure | 100 | 75 | — |
| S. aureus (MRSA),Improvement | 0 | 0 | — |
| S. aureus (MRSA),Clinical Failure | 0 | 0 | — |
| S. aureus (MRSA),Unknown | 0 | 0 | — |
| S. aureus (MRSA),Missing | 0 | 25 | — |
| S. aureus (MSSA),Clinical Cure | 91.5 | 86.4 | 100 |
| S. aureus (MSSA),Improvement | 4.3 | 4.5 | 0 |
| S. aureus (MSSA),Clinical Failure | 2.1 | 2.3 | 0 |
| S. aureus (MSSA),Unknown | 0 | 0 | 0 |
| S. aureus (MSSA),Missing | 2.1 | 6.8 | 0 |
| S. agalactiae, Clinical Cure | — | 100 | — |
| S. agalactiae, Improvement | — | 0 | — |
| S. agalactiae, Clinical Failure | — | 0 | — |
| S. agalactiae, Unknown | — | 0 | — |
| S. anginosus, Clinical Cure | 100 | — | — |
| S. anginosus, Improvement | 0 | — | — |
| S. anginosus, Clinical Failure | 0 | — | — |
| S. anginosus, Unknown | 0 | — | — |
| S. constellatus, Clinical Cure | — | 100 | — |
| S. constellatus, Improvement | — | 0 | — |
| S. constellatus, Clinical Failure | — | 0 | — |
| S. constellatus, Unknown | — | 0 | — |
| S. intermedius, Clinical Cure | — | 100 | — |
| S. intermedius, Improvement | — | 0 | — |
| S. intermedius, Clinical Failure | — | 0 | — |
| S. intermedius, Unknown | — | 0 | — |
| S. pyogenes, Clinical Cure | 80 | 50 | 100 |
| S. pyogenes, Improvement | 0 | 25 | 0 |
| S. pyogenes, Clinical Failure | 20 | 0 | 0 |
| S. pyogenes, Unknown | 0 | 0 | 0 |
| S. pyogenes, Missing | 0 | 25 | 0 |
| E. faecalis, Clinical Cure | 100 | 100 | — |
| E. faecalis, Improvement | 0 | 0 | — |
| E. faecalis, Clinical Failure | 0 | 0 | — |
| E. faecalis, Unknown | 0 | 0 | — |
Definitions used for the Sponsor assessment were the same as those used for the Investigator assessment. The occurrence of any of the following conditions resulted in reassignment by the Sponsor to clinical failure: 1) assessment of clinical failure at a previous time point, 2) Cohorts 1-4: receipt of concomitant antibiotic with activity against participant's isolate of disease under study prior to evaluation time point; Cohort 5: receipt of rescue therapy (additional antibiotic therapy initiated ≥48 hrs after study drug start), 3) unplanned surgical procedure (e.g., incision and drainage of abscess, major debridement, amputation) for non-improving or worsening infection after 72 hrs of study drug treatment. Presented for the microbiological intent-to-treat (microITT) population: all randomized (or enrolled in Cohort 5) participants who had at least 1 Gram-positive pathogen isolated at Baseline.
| percentage of participants | Dalbavancin Single-dose | Dalbavancin Two-dose | Comparator |
|---|---|---|---|
| S. aureus (MRSA),Cure | 100 | 75 | — |
| S. aureus (MRSA),Improvement | 0 | 0 | — |
| S. aureus (MRSA),Failure | 0 | 25 | — |
| S. aureus (MRSA),Unknown | 0 | 0 | — |
| S. aureus (MSSA),Cure | 91.5 | 86.4 | 100 |
| S. aureus (MSSA),Improvement | 4.3 | 4.5 | 0 |
| S. aureus (MSSA),Failure | 2.1 | 4.5 | 0 |
| S. aureus (MSSA),Unknown | 0 | 0 | 0 |
| S. aureus (MSSA),Missing | 2.1 | 4.5 | 0 |
| S. agalactiae, Cure | — | 100 | — |
| S. agalactiae, Improvement | — | 0 | — |
| S. agalactiae, Failure | — | 0 | — |
| S. agalactiae, Unknown | — | 0 | — |
| S. anginosus, Cure | 100 | — | — |
| S. anginosus, Improvement | 0 | — | — |
| S. anginosus, Failure | 0 | — | — |
| S. anginosus, Unknown | 0 | — | — |
| S. constellatus, Cure | — | 100 | — |
| S. constellatus, Improvement | — | 0 | — |
| S. constellatus, Failure | — | 0 | — |
| S. constellatus, Unknown | — | 0 | — |
| S. intermedius, Cure | — | 100 | — |
| S. intermedius, Improvement | — | 0 | — |
| S. intermedius, Failure | — | 0 | — |
| S. intermedius, Unknown | — | 0 | — |
| S. pyogenes, Cure | 80 | 50 | 100 |
| S. pyogenes, Improvement | 0 | 25 | 0 |
| S. pyogenes, Failure | 20 | 0 | 0 |
| S. pyogenes, Unknown | 0 | 0 | 0 |
| S. pyogenes, Missing | 0 | 25 | 0 |
| E. faecalis, Cure | 100 | 100 | — |
| E. faecalis, Improvement | 0 | 0 | — |
| E. faecalis, Failure | 0 | 0 | — |
| E. faecalis, Unknown | 0 | 0 | — |
Cure: Resolution of clinical signs and symptoms of infection (CSSI) compared to Baseline. No additional antibacterial Tx required for disease under study. Failure: Persistence or progression of Baseline CSSI after 48 hours of Tx OR development of new findings consistent with active infection. Unknown: Extenuating circumstances precluding classification to Cure or Failure. Presented for the microbiological intent-to-treat (microITT) population: all randomized (or enrolled in Cohort 5) participants who had at least 1 Gram-positive pathogen isolated at Baseline.
| percentage of participants | Dalbavancin Single-dose | Dalbavancin Two-dose | Comparator |
|---|---|---|---|
| S. aureus (MRSA),Clinical Cure | 100 | 75 | — |
| S. aureus (MRSA),Clinical Failure | 0 | 0 | — |
| S. aureus (MRSA),Unknown | 0 | 0 | — |
| S. aureus (MRSA),Missing | 0 | 25 | — |
| S. aureus (MSSA),Clinical Cure | 95.7 | 90.9 | 100 |
| S. aureus (MSSA),Clinical Failure | 2.1 | 2.3 | 0 |
| S. aureus (MSSA),Unknown | 0 | 0 | 0 |
| S. aureus (MSSA),Missing | 2.2 | 6.8 | 0 |
| S. agalactiae, Clinical Cure | — | 100 | — |
| S. agalactiae, Clinical Failure | — | 0 | — |
| S. agalactiae, Unknown | — | 0 | — |
| S. anginosus, Clinical Cure | 100 | — | — |
| S. anginosus, Clinical Failure | 0 | — | — |
| S. anginosus, Unknown | 0 | — | — |
| S. constellatus, Clinical Cure | — | 100 | — |
| S. constellatus, Clinical Failure | — | 0 | — |
| S. constellatus, Unknown | — | 0 | — |
| S. intermedius, Clinical Cure | — | 100 | — |
| S. intermedius, Clinical Failure | — | 0 | — |
| S. intermedius, Unknown | — | 0 | — |
| S. pyogenes, Clinical Cure | 80 | 75 | 100 |
| S. pyogenes, Clinical Failure | 20 | 0 | 0 |
| S. pyogenes, Unknown | 0 | 0 | 0 |
| S. pyogenes, Missing | 0 | 25 | 0 |
| E. faecalis, Clinical Cure | 100 | 100 | — |
| E. faecalis, Clinical Failure | 0 | 0 | — |
| E. faecalis, Unknown | 0 | 0 | — |
Definitions used for the Sponsor assessment were the same as those used for the Investigator assessment. The occurrence of any of the following conditions resulted in reassignment by the Sponsor to clinical failure: 1) assessment of clinical failure at a previous time point, 2) Cohorts 1-4: receipt of concomitant antibiotic with activity against participant's isolate of disease under study prior to evaluation time point; Cohort 5: receipt of rescue therapy (additional antibiotic therapy initiated ≥48 hrs after study drug start), 3) unplanned surgical procedure (e.g., incision and drainage of abscess, major debridement, amputation) for non-improving or worsening infection after 72 hrs of study drug treatment. Presented for the microbiological intent-to-treat (microITT) population: all randomized (or enrolled in Cohort 5) participants who had at least 1 Gram-positive pathogen isolated at Baseline.
| percentage of participants | Dalbavancin Single-dose | Dalbavancin Two-dose | Comparator |
|---|---|---|---|
| S. aureus (MRSA),Cure | 100 | 75 | — |
| S. aureus (MRSA),Failure | 0 | 25 | — |
| S. aureus (MRSA),Unknown | 0 | 0 | — |
| S. aureus (MSSA),Cure | 91.5 | 90.9 | 100 |
| S. aureus (MSSA),Failure | 2.1 | 4.5 | 0 |
| S. aureus (MSSA),Unknown | 4.3 | 0 | 0 |
| S. aureus (MSSA),Missing | 2.1 | 4.5 | 0 |
| S. agalactiae, Cure | — | 100 | — |
| S. agalactiae, Failure | — | 0 | — |
| S. agalactiae, Unknown | — | 0 | — |
| S. anginosus, Cure | 100 | — | — |
| S. anginosus, Failure | 0 | — | — |
| S. anginosus, Unknown | 0 | — | — |
| S. constellatus, Cure | — | 100 | — |
| S. constellatus, Failure | — | 0 | — |
| S. constellatus, Unknown | — | 0 | — |
| S. intermedius, Cure | — | 100 | — |
| S. intermedius, Failure | — | 0 | — |
| S. intermedius, Unknown | — | 0 | — |
| S. pyogenes, Cure | 80 | 75 | 100 |
| S. pyogenes, Failure | 20 | 0 | 0 |
| S. pyogenes, Unknown | 0 | 0 | 0 |
| S. pyogenes, Missing | 0 | 25 | 0 |
| E. faecalis, Cure | 100 | 100 | — |
| E. faecalis, Failure | 0 | 0 | — |
| E. faecalis, Unknown | 0 | 0 | — |
Cure: Resolution of clinical signs and symptoms of infection (CSSI) compared to Baseline. No additional antibacterial Tx required for disease under study. Failure: Persistence or progression of Baseline CSSI after 48 hours of Tx OR development of new findings consistent with active infection. Unknown: Extenuating circumstances precluding classification to Cure or Failure. Presented for the microbiological intent-to-treat (microITT) population: all randomized (or enrolled in Cohort 5) participants who had at least 1 Gram-positive pathogen isolated at Baseline.
| percentage of participants | Dalbavancin Single-dose | Dalbavancin Two-dose | Comparator |
|---|---|---|---|
| S. aureus (MRSA),Clinical Cure | 50 | 50 | — |
| S. aureus (MRSA),Clinical Failure | 0 | 0 | — |
| S. aureus (MRSA),Unknown | 50 | 25 | — |
| S. aureus (MRSA),Missing | 0 | 25 | — |
| S. aureus (MSSA),Clinical Cure | 95.7 | 88.6 | 100 |
| S. aureus (MSSA),Clinical Failure | 2.1 | 2.3 | 0 |
| S. aureus (MSSA),Unknown | 2.1 | 0 | 0 |
| S. aureus (MSSA),Missing | 0 | 9.1 | 0 |
| S. agalactiae, Clinical Cure | — | 100 | — |
| S. agalactiae, Clinical Failure | — | 0 | — |
| S. agalactiae, Unknown | — | 0 | — |
| S. anginosus, Clinical Cure | 100 | — | — |
| S. anginosus, Clinical Failure | 0 | — | — |
| S. anginosus, Unknown | 0 | — | — |
| S. constellatus, Clinical Cure | — | 100 | — |
| S. constellatus, Clinical Failure | — | 0 | — |
| S. constellatus, Unknown | — | 0 | — |
| S. intermedius, Clinical Cure | — | 100 | — |
| S. intermedius, Clinical Failure | — | 0 | — |
| S. intermedius, Unknown | — | 0 | — |
| S. pyogenes, Clinical Cure | 80 | 75 | 100 |
| S. pyogenes, Clinical Failure | 20 | 0 | 0 |
| S. pyogenes, Unknown | 0 | 0 | 0 |
| S. pyogenes, Missing | 0 | 25 | 0 |
| E. faecalis, Clinical Cure | 100 | 100 | — |
| E. faecalis, Clinical Failure | 0 | 0 | — |
| E. faecalis, Unknown | 0 | 0 | — |
Definitions used for the Sponsor assessment were the same as those used for the Investigator assessment. The occurrence of any of the following conditions resulted in reassignment by the Sponsor to clinical failure: 1) assessment of clinical failure at a previous time point, 2) Cohorts 1-4: receipt of concomitant antibiotic with activity against participant's isolate of disease under study prior to evaluation time point; Cohort 5: receipt of rescue therapy (additional antibiotic therapy initiated ≥48 hrs after study drug start), 3) unplanned surgical procedure (e.g., incision and drainage of abscess, major debridement, amputation) for non-improving or worsening infection after 72 hrs of study drug treatment. Presented for the microbiological intent-to-treat (microITT) population: all randomized (or enrolled in Cohort 5) participants who had at least 1 Gram-positive pathogen isolated at Baseline.
| percentage of participants | Dalbavancin Single-dose | Dalbavancin Two-dose | Comparator |
|---|---|---|---|
| S. aureus (MRSA),Cure | 50 | 50 | — |
| S. aureus (MRSA),Failure | 0 | 25 | — |
| S. aureus (MRSA),Unknown | 0 | 0 | — |
| S. aureus (MRSA),Missing | 50 | 25 | — |
| S. aureus (MSSA),Cure | 93.6 | 88.6 | 100 |
| S. aureus (MSSA),Failure | 2.1 | 4.5 | 0 |
| S. aureus (MSSA),Unknown | 2.1 | 0 | 0 |
| S. aureus (MSSA),Missing | 2.1 | 6.8 | 0 |
| S. agalactiae, Cure | — | 100 | — |
| S. agalactiae, Failure | — | 0 | — |
| S. agalactiae, Unknown | — | 0 | — |
| S. anginosus, Cure | 100 | — | — |
| S. anginosus, Failure | 0 | — | — |
| S. anginosus, Unknown | 0 | — | — |
| S. constellatus, Cure | — | 100 | — |
| S. constellatus, Failure | — | 0 | — |
| S. constellatus, Unknown | — | 0 | — |
| S. intermedius, Cure | — | 100 | — |
| S. intermedius, Failure | — | 0 | — |
| S. intermedius, Unknown | — | 0 | — |
| S. pyogenes, Cure | 80 | 75 | 100 |
| S. pyogenes, Failure | 20 | 0 | 0 |
| S. pyogenes, Unknown | 0 | 0 | 0 |
| S. pyogenes, Missing | 0 | 25 | 0 |
| E. faecalis, Cure | 100 | 100 | — |
| E. faecalis, Failure | 0 | 0 | — |
| E. faecalis, Unknown | 0 | 0 | — |
Eradication: Source specimen demonstrated absence of the original Baseline pathogen. Presumed eradication: Source specimen was not available to culture and the participant was assessed as a clinical responder. Persistence: Source specimen demonstrated continued presence of the original Baseline pathogen. Presumed persistence: Source specimen was not available to culture and the participant was assessed as a clinical non-responder. Indeterminate: Source specimen was not available to culture and the participant's clinical response was unknown or missing. Presented for the microbiological intent-to-treat (microITT) population: all randomized (or enrolled in Cohort 5) participants who had at least 1 Gram-positive pathogen isolated at Baseline.
| percentage of participants | Dalbavancin Single-dose | Dalbavancin Two-dose | Comparator |
|---|---|---|---|
| Eradication | 0 | 1.9 | 0 |
| Presumed eradication | 98.1 | 94.4 | 88.9 |
| Persistence | 0 | 1.9 | 0 |
| Presumed persistence | 1.9 | 1.9 | 5.6 |
| Indeterminate | 0 | 0 | 5.6 |
Eradication: Source specimen demonstrated absence of the original Baseline pathogen. Presumed eradication: Source specimen was not available to culture and the participant was assessed as a clinical cure or improvement. Persistence: Source specimen demonstrated continued presence of the original Baseline pathogen. Presumed persistence: Source specimen was not available to culture and the participant was assessed as a clinical failure. Indeterminate: Source specimen was not available to culture and the participant's clinical response was unknown or missing. Presented for the microbiological intent-to-treat (microITT) population: all randomized (or enrolled in Cohort 5) participants who had at least 1 Gram-positive pathogen isolated at Baseline.
| percentage of participants | Dalbavancin Single-dose | Dalbavancin Two-dose | Comparator |
|---|---|---|---|
| Eradication | 0 | 1.9 | 0 |
| Presumed eradication | 96.2 | 92.6 | 100 |
| Persistence | 0 | 1.9 | 0 |
| Presumed persistence | 1.9 | 1.9 | 0 |
| Indeterminate | 1.9 | 1.9 | 0 |
Eradication: Source specimen demonstrated absence of the original Baseline pathogen. Presumed eradication: Source specimen was not available to culture and the participant was assessed as a clinical cure. Persistence: Source specimen demonstrated continued presence of the original Baseline pathogen. Presumed persistence: Source specimen was not available to culture and the participant was assessed as a clinical failure. Indeterminate: Source specimen was not available to culture and the participant's clinical response was unknown or missing. Presented for the microbiological intent-to-treat (microITT) population: all randomized (or enrolled in Cohort 5) participants who had at least 1 Gram-positive pathogen isolated at Baseline.
| percentage of participants | Dalbavancin Single-dose | Dalbavancin Two-dose | Comparator |
|---|---|---|---|
| Eradication | 0 | 1.9 | 0 |
| Presumed eradication | 92.3 | 92.6 | 100 |
| Persistence | 0 | 0 | 0 |
| Presumed persistence | 1.9 | 3.7 | 0 |
| Indeterminate | 5.8 | 1.9 | 0 |
Eradication: Source specimen demonstrated absence of the original Baseline pathogen. Presumed eradication: Source specimen was not available to culture and the participant was assessed as a clinical cure. Persistence: Source specimen demonstrated continued presence of the original Baseline pathogen. Presumed persistence: Source specimen was not available to culture and the participant was assessed as a clinical failure. Indeterminate: Source specimen was not available to culture and the participant's clinical response was unknown or missing. Presented for the microbiological intent-to-treat (microITT) population: all randomized (or enrolled in Cohort 5) participants who had at least 1 Gram-positive pathogen isolated at Baseline.
| percentage of participants | Dalbavancin Single-dose | Dalbavancin Two-dose | Comparator |
|---|---|---|---|
| Eradication | 0 | 1.9 | 0 |
| Presumed eradication | 94.2 | 88.9 | 100 |
| Persistence | 0 | 0 | 0 |
| Presumed persistence | 1.9 | 3.7 | 0 |
| Indeterminate | 3.8 | 5.6 | 0 |
Eradication: Source specimen demonstrated absence of the original Baseline pathogen. Presumed eradication: Source specimen was not available to culture and the participant was assessed as a clinical responder. Persistence: Source specimen demonstrated continued presence of the original Baseline pathogen. Presumed persistence: Source specimen was not available to culture and the participant was assessed as a clinical non-responder. Indeterminate: Source specimen was not available to culture and the participant's clinical response was unknown or missing., Presented for the microbiological intent-to-treat (microITT) population: all randomized (or enrolled in Cohort 5) participants who had at least 1 Gram-positive pathogen isolated at Baseline.
| percentage of participants | Dalbavancin Single-dose | Dalbavancin Two-dose | Comparator |
|---|---|---|---|
| S. aureus (MRSA), Eradication | 0 | 0 | — |
| S. aureus (MRSA), Presumed eradication | 100 | 100 | — |
| S. aureus (MRSA), Persistence | 0 | 0 | — |
| S. aureus (MRSA), Presumed persistence | 0 | 0 | — |
| S. aureus (MRSA), Indeterminate | 0 | 0 | — |
| S. aureus (MSSA), Eradication | 0 | 2.3 | 0 |
| S. aureus (MSSA), Presumed eradication | 97.9 | 90.9 | 85.7 |
| S. aureus (MSSA), Persistence | 0 | 2.3 | 0 |
| S. aureus (MSSA), Presumed persistence | 2.1 | 2.3 | 7.1 |
| S. aureus (MSSA), Indeterminate | 0 | 0 | 7.1 |
| S. aureus (MSSA), Missing | 0 | 2.3 | 0 |
| S. agalactiae, Eradication | — | 0 | — |
| S. agalactiae, Presumed eradication | — | 100 | — |
| S. agalactiae, Persistence | — | 0 | — |
| S. agalactiae, Presumed persistence | — | 0 | — |
| S. agalactiae, Indeterminate | — | 0 | — |
| S. anginosus, Eradication | 0 | — | — |
| S. anginosus, Presumed eradication | 100 | — | — |
| S. anginosus, Persistence | 0 | — | — |
| S. anginosus, Presumed persistence | 0 | — | — |
| S. anginosus, Indeterminate | 0 | — | — |
| S. constellatus, Eradication | — | 0 | — |
| S. constellatus, Presumed eradication | — | 100 | — |
| S. constellatus, Persistence | — | 0 | — |
| S. constellatus, Presumed persistence | — | 0 | — |
| S. constellatus, Indeterminate | — | 0 | — |
| S. intermedius, Eradication | — | 0 | — |
| S. intermedius, Presumed eradication | — | 100 | — |
| S. intermedius, Persistence | — | 0 | — |
| S. intermedius, Presumed persistence | — | 0 | — |
| S. intermedius, Indeterminate | — | 0 | — |
| S. mitis/oralis, Eradication | 0 | 0 | 0 |
| S. mitis/oralis, Presumed eradication | 100 | 100 | 100 |
| S. mitis/oralis, Persistence | 0 | 0 | 0 |
| S. mitis/oralis, Presumed persistence | 0 | 0 | 0 |
| S. mitis/oralis, Indeterminate | 0 | 0 | 0 |
| S. pyogenes, Eradication | 0 | 0 | 0 |
| S. pyogenes, Presumed eradication | 80 | 75 | 100 |
| S. pyogenes, Persistence | 0 | 0 | 0 |
| S. pyogenes, Presumed persistence | 20 | 0 | 0 |
| S. pyogenes, Indeterminate | 0 | 0 | 0 |
| S. pyogenes, Missing | 0 | 25 | 0 |
| E. faecalis, Eradication | 0 | 0 | — |
| E. faecalis, Presumed eradication | 100 | 100 | — |
| E. faecalis, Persistence | 0 | 0 | — |
| E. faecalis, Presumed persistence | 0 | 0 | — |
| E. faecalis, Indeterminate | 0 | 0 | — |
| E. hirae, Eradication | 0 | — | — |
| E. hirae, Presumed eradication | 100 | — | — |
| E. hirae, Persistence | 0 | — | — |
| E. hirae, Presumed persistence | 0 | — | — |
| E. hirae, Indeterminate | 0 | — | — |
| G. morbillorum, Eradication | 0 | — | — |
| G. morbillorum, Presumed eradication | 100 | — | — |
| G. morbillorum, Persistence | 0 | — | — |
| G. morbillorum, Presumed persistence | 0 | — | — |
| G. morbillorum, Indeterminate | 0 | — | — |
| L. lactis, Eradication | 0 | — | — |
| L. lactis, Presumed eradication | 100 | — | — |
| L. lactis, Persistence | 0 | — | — |
| L. lactis, Presumed persistence | 0 | — | — |
| L. lactis, Indeterminate | 0 | — | — |
Eradication: Source specimen demonstrated absence of the original Baseline pathogen. Presumed eradication: Source specimen was not available to culture and the participant was assessed as a clinical cure or improvement. Persistence: Source specimen demonstrated continued presence of the original Baseline pathogen. Presumed persistence: Source specimen was not available to culture and the participant was assessed as a clinical failure. Indeterminate: Source specimen was not available to culture and the participant's clinical response was unknown or missing. Presented for the microbiological intent-to-treat (microITT) population: all randomized (or enrolled in Cohort 5) participants who had at least 1 Gram-positive pathogen isolated at Baseline.
| percentage of participants | Dalbavancin Single-dose | Dalbavancin Two-dose | Comparator |
|---|---|---|---|
| S. aureus (MRSA), Eradication | 0 | 0 | — |
| S. aureus (MRSA), Presumed eradication | 100 | 75 | — |
| S. aureus (MRSA), Persistence | 0 | 0 | — |
| S. aureus (MRSA), Presumed persistence | 0 | 25 | — |
| S. aureus (MRSA), Indeterminate | 0 | 0 | — |
| S. aureus (MSSA), Eradication | 0 | 2.3 | 0 |
| S. aureus (MSSA), Presumed eradication | 95.7 | 88.6 | 100 |
| S. aureus (MSSA), Persistence | 0 | 2.3 | 0 |
| S. aureus (MSSA), Presumed persistence | 2.1 | 2.3 | 0 |
| S. aureus (MSSA), Indeterminate | 2.1 | 2.3 | 0 |
| S. aureus (MSSA), Missing | 0 | 2.3 | 0 |
| S. agalactiae, Eradication | — | 0 | — |
| S. agalactiae, Presumed eradication | — | 100 | — |
| S. agalactiae, Persistence | — | 0 | — |
| S. agalactiae, Presumed persistence | — | 0 | — |
| S. agalactiae, Indeterminate | — | 0 | — |
| S. anginosus, Eradication | 0 | — | — |
| S. anginosus, Presumed eradication | 100 | — | — |
| S. anginosus, Persistence | 0 | — | — |
| S. anginosus, Presumed persistence | 0 | — | — |
| S. anginosus, Indeterminate | 0 | — | — |
| S. constellatus, Eradication | — | 0 | — |
| S. constellatus, Presumed eradication | — | 100 | — |
| S. constellatus, Persistence | — | 0 | — |
| S. constellatus, Presumed persistence | — | 0 | — |
| S. constellatus, Indeterminate | — | 0 | — |
| S. intermedius, Eradication | — | 0 | — |
| S. intermedius, Presumed eradication | — | 100 | — |
| S. intermedius, Persistence | — | 0 | — |
| S. intermedius, Presumed persistence | — | 0 | — |
| S. intermedius, Indeterminate | — | 0 | — |
| S. mitis/oralis, Eradication | 0 | 0 | 0 |
| S. mitis/oralis, Presumed eradication | 100 | 100 | 100 |
| S. mitis/oralis, Persistence | 0 | 0 | 0 |
| S. mitis/oralis, Presumed persistence | 0 | 0 | 0 |
| S. mitis/oralis, Indeterminate | 0 | 0 | 0 |
| S. pyogenes, Eradication | 0 | 0 | 0 |
| S. pyogenes, Presumed eradication | 80 | 75 | 100 |
| S. pyogenes, Persistence | 0 | 0 | 0 |
| S. pyogenes, Presumed persistence | 20 | 0 | 0 |
| S. pyogenes, Indeterminate | 0 | 0 | 0 |
| S. pyogenes, Missing | 0 | 25 | 0 |
| E. faecalis, Eradication | 0 | 0 | — |
| E. faecalis, Presumed eradication | 100 | 100 | — |
| E. faecalis, Persistence | 0 | 0 | — |
| E. faecalis, Presumed persistence | 0 | 0 | — |
| E. faecalis, Indeterminate | 0 | 0 | — |
| E. hirae, Eradication | 0 | — | — |
| E. hirae, Presumed eradication | 0 | — | — |
| E. hirae, Persistence | 0 | — | — |
| E. hirae, Presumed persistence | 0 | — | — |
| E. hirae, Indeterminate | 100 | — | — |
| G. morbillorum, Eradication | 0 | — | — |
| G. morbillorum, Presumed eradication | 100 | — | — |
| G. morbillorum, Persistence | 0 | — | — |
| G. morbillorum, Presumed persistence | 0 | — | — |
| G. morbillorum, Indeterminate | 0 | — | — |
| L. lactis, Eradication | 0 | — | — |
| L. lactis, Presumed eradication | 100 | — | — |
| L. lactis, Persistence | 0 | — | — |
| L. lactis, Presumed persistence | 0 | — | — |
| L. lactis, Indeterminate | 0 | — | — |
Eradication: Source specimen demonstrated absence of the original Baseline pathogen. Presumed eradication: Source specimen was not available to culture and the participant was assessed as a clinical cure. Persistence: Source specimen demonstrated continued presence of the original Baseline pathogen. Presumed persistence: Source specimen was not available to culture and the participant was assessed as a clinical failure. Indeterminate: Source specimen was not available to culture and the participant's clinical response was unknown or missing. Presented for the microbiological intent-to-treat (microITT) population: all randomized (or enrolled in Cohort 5) participants who had at least 1 Gram-positive pathogen isolated at Baseline.
| percentage of participants | Dalbavancin Single-dose | Dalbavancin Two-dose | Comparator |
|---|---|---|---|
| S. aureus (MRSA), Eradication | 0 | 0 | — |
| S. aureus (MRSA), Presumed eradication | 100 | 75 | — |
| S. aureus (MRSA), Persistence | 0 | 0 | — |
| S. aureus (MRSA), Presumed persistence | 0 | 25 | — |
| S. aureus (MRSA), Indeterminate | 0 | 0 | — |
| S. aureus (MSSA), Eradication | 0 | 2.3 | 0 |
| S. aureus (MSSA), Presumed eradication | 91.5 | 88.6 | 100 |
| S. aureus (MSSA), Persistence | 0 | 0 | 0 |
| S. aureus (MSSA), Presumed persistence | 2.1 | 4.5 | 0 |
| S. aureus (MSSA), Indeterminate | 6.4 | 2.3 | 0 |
| S. aureus (MSSA), Missing | 0 | 2.3 | 0 |
| S. agalactiae, Eradication | — | 0 | — |
| S. agalactiae, Presumed eradication | — | 100 | — |
| S. agalactiae, Persistence | — | 0 | — |
| S. agalactiae, Presumed persistence | — | 0 | — |
| S. agalactiae, Indeterminate | — | 0 | — |
| S. anginosus, Eradication | 0 | — | — |
| S. anginosus, Presumed eradication | 100 | — | — |
| S. anginosus, Persistence | 0 | — | — |
| S. anginosus, Presumed persistence | 0 | — | — |
| S. anginosus, Indeterminate | 0 | — | — |
| S. constellatus, Eradication | — | 0 | — |
| S. constellatus, Presumed eradication | — | 100 | — |
| S. constellatus, Persistence | — | 0 | — |
| S. constellatus, Presumed persistence | — | 0 | — |
| S. constellatus, Indeterminate | — | 0 | — |
| S. intermedius, Eradication | — | 0 | — |
| S. intermedius, Presumed eradication | — | 100 | — |
| S. intermedius, Persistence | — | 0 | — |
| S. intermedius, Presumed persistence | — | 0 | — |
| S. intermedius, Indeterminate | — | 0 | — |
| S. mitis/oralis, Eradication | 0 | 0 | 0 |
| S. mitis/oralis, Presumed eradication | 100 | 100 | 100 |
| S. mitis/oralis, Persistence | 0 | 0 | 0 |
| S. mitis/oralis, Presumed persistence | 0 | 0 | 0 |
| S. mitis/oralis, Indeterminate | 0 | 0 | 0 |
| S. pyogenes, Eradication | 0 | 0 | 0 |
| S. pyogenes, Presumed eradication | 80 | 75 | 100 |
| S. pyogenes, Persistence | 0 | 0 | 0 |
| S. pyogenes, Presumed persistence | 20 | 0 | 0 |
| S. pyogenes, Indeterminate | 0 | 0 | 0 |
| S. pyogenes, Missing | 0 | 25 | 0 |
| E. faecalis, Eradication | 0 | 0 | — |
| E. faecalis, Presumed eradication | 100 | 100 | — |
| E. faecalis, Persistence | 0 | 0 | — |
| E. faecalis, Presumed persistence | 0 | 0 | — |
| E. faecalis, Indeterminate | 0 | 0 | — |
| E. hirae, Eradication | 0 | — | — |
| E. hirae, Presumed eradication | 100 | — | — |
| E. hirae, Persistence | 0 | — | — |
| E. hirae, Presumed persistence | 0 | — | — |
| E. hirae, Indeterminate | 0 | — | — |
| G. morbillorum, Eradication | 0 | — | — |
| G. morbillorum, Presumed eradication | 100 | — | — |
| G. morbillorum, Persistence | 0 | — | — |
| G. morbillorum, Presumed persistence | 0 | — | — |
| G. morbillorum, Indeterminate | 0 | — | — |
| L. lactis, Eradication | 0 | — | — |
| L. lactis, Presumed eradication | 100 | — | — |
| L. lactis, Persistence | 0 | — | — |
| L. lactis, Presumed persistence | 0 | — | — |
| L. lactis, Indeterminate | 0 | — | — |
Eradication: Source specimen demonstrated absence of the original Baseline pathogen. Presumed eradication: Source specimen was not available to culture and the participant was assessed as a clinical cure. Persistence: Source specimen demonstrated continued presence of the original Baseline pathogen. Presumed persistence: Source specimen was not available to culture and the participant was assessed as a clinical failure. Indeterminate: Source specimen was not available to culture and the participant's clinical response was unknown or missing. Presented for the microbiological intent-to-treat (microITT) population: all randomized (or enrolled in Cohort 5) participants who had at least 1 Gram-positive pathogen isolated at Baseline.
| percentage of participants | Dalbavancin Single-dose | Dalbavancin Two-dose | Comparator |
|---|---|---|---|
| S. aureus (MRSA), Eradication | 0 | 0 | — |
| S. aureus (MRSA), Presumed eradication | 50 | 50 | — |
| S. aureus (MRSA), Persistence | 0 | 0 | — |
| S. aureus (MRSA), Presumed persistence | 0 | 25 | — |
| S. aureus (MRSA), Indeterminate | 50 | 25 | — |
| S. aureus (MSSA), Eradication | 0 | 2.3 | 0 |
| S. aureus (MSSA), Presumed eradication | 93.6 | 86.4 | 100 |
| S. aureus (MSSA), Persistence | 0 | 0 | 0 |
| S. aureus (MSSA), Presumed persistence | 2.1 | 4.5 | 0 |
| S. aureus (MSSA), Indeterminate | 4.3 | 4.5 | 0 |
| S. aureus (MSSA), Missing | 0 | 2.3 | 0 |
| S. agalactiae, Eradication | — | 0 | — |
| S. agalactiae, Presumed eradication | — | 100 | — |
| S. agalactiae, Persistence | — | 0 | — |
| S. agalactiae, Presumed persistence | — | 0 | — |
| S. agalactiae, Indeterminate | — | 0 | — |
| S. anginosus, Eradication | 0 | — | — |
| S. anginosus, Presumed eradication | 100 | — | — |
| S. anginosus, Persistence | 0 | — | — |
| S. anginosus, Presumed persistence | 0 | — | — |
| S. anginosus, Indeterminate | 0 | — | — |
| S. constellatus, Eradication | — | 0 | — |
| S. constellatus, Presumed eradication | — | 100 | — |
| S. constellatus, Persistence | — | 0 | — |
| S. constellatus, Presumed persistence | — | 0 | — |
| S. constellatus, Indeterminate | — | 0 | — |
| S. intermedius, Eradication | — | 0 | — |
| S. intermedius, Presumed eradication | — | 100 | — |
| S. intermedius, Persistence | — | 0 | — |
| S. intermedius, Presumed persistence | — | 0 | — |
| S. intermedius, Indeterminate | — | 0 | — |
| S. mitis/oralis, Eradication | 0 | 0 | 0 |
| S. mitis/oralis, Presumed eradication | 100 | 100 | 100 |
| S. mitis/oralis, Persistence | 0 | 0 | 0 |
| S. mitis/oralis, Presumed persistence | 0 | 0 | 0 |
| S. mitis/oralis, Indeterminate | 0 | 0 | 0 |
| S. pyogenes, Eradication | 0 | 0 | 0 |
| S. pyogenes, Presumed eradication | 80 | 75 | 100 |
| S. pyogenes, Persistence | 0 | 0 | 0 |
| S. pyogenes, Presumed persistence | 20 | 0 | 0 |
| S. pyogenes, Indeterminate | 0 | 0 | 0 |
| S. pyogenes, Missing | 0 | 25 | 0 |
| E. faecalis, Eradication | 0 | 0 | — |
| E. faecalis, Presumed eradication | 100 | 100 | — |
| E. faecalis, Persistence | 0 | 0 | — |
| E. faecalis, Presumed persistence | 0 | 0 | — |
| E. faecalis, Indeterminate | 0 | 0 | — |
| E. hirae, Eradication | 0 | — | — |
| E. hirae, Presumed eradication | 100 | — | — |
| E. hirae, Persistence | 0 | — | — |
| E. hirae, Presumed persistence | 0 | — | — |
| E. hirae, Indeterminate | 0 | — | — |
| G. morbillorum, Eradication | 0 | — | — |
| G. morbillorum, Presumed eradication | 100 | — | — |
| G. morbillorum, Persistence | 0 | — | — |
| G. morbillorum, Presumed persistence | 0 | — | — |
| G. morbillorum, Indeterminate | 0 | — | — |
| L. lactis, Eradication | 0 | — | — |
| L. lactis, Presumed eradication | 100 | — | — |
| L. lactis, Persistence | 0 | — | — |
| L. lactis, Presumed persistence | 0 | — | — |
| L. lactis, Indeterminate | 0 | — | — |
All-cause mortality was determined for the participants in Cohort 5 (birth to \< 3 months) at the Test of Cure visit.
| Participants | Birth to < 3 Months of Age (Cohort 5) |
|---|---|
| All-cause Mortality at the Test of Cure (TOC) Visit Among Cohort 5 Participants | 0 |
The population pharmacokinetic (PK) profile of dalbavancin was assessed using a sparse sampling approach. Plasma PK samples were collected from participants receiving dalbavancin treatment (single-dose and two-dose arms) at 30 minutes and at 2 hours (Day 1), at 48-72 hours (Day 3-4), at 168 ± 24 hours (Day 8 ± 1), and at 312 ± 48 hours and analyzed for dalbavancin concentration.
| µg/mL | Birth to < 3 Months of Age (Cohort 5) | 3 Months to < 2 Years Old (Cohort 4) | 2 Years to < 6 Years Old (Cohort 3) | Participants Aged 6 Years to < 12 Years Old | 12 Years to 17 Years Old (Cohort 1) |
|---|---|---|---|---|---|
| 30 min (end of infusion) | 212.43 ± 23.32 | 268.02 ± 44.90 | 219.45 ± 66.72 | 211.30 ± 34.26 | 233.58 ± 46.44 |
| 2 hrs after start of IV | 133.83 ± 24.66 | 196.51 ± 53.44 | 149.28 ± 43.40 | 165.75 ± 37.46 | 162.54 ± 36.85 |
| 48-72 hrs after start of IV | 53.53 ± 24.48 | 61.32 ± 40.08 | 56.68 ± 46.25 | 56.93 ± 39.79 | 60.92 ± 28.68 |
| 168 hrs after start of IV | 16.89 ± 35.12 | 28.80 ± 119.04 | 24.10 ± 80.90 | 26.25 ± 51.38 | 31.41 ± 31.24 |
| 312 hrs after start of IV | 4.94 ± 47.91 | 15.24 ± 47.97 | 12.74 ± 45.62 | 15.35 ± 39.40 | 20.75 ± 37.71 |
Collected over All-cause mortality and adverse events were collected from the time informed consent was signed through the Final Visit. Median time on follow-up was 54.0 days for the Dalbavancin Single-dose and Dalbavancin Two-dose groups and 54.5 days for the Comparator group.. Non-serious events are listed at a 2% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Dalbavancin Single-dose | 0/91 (0%) | 3/91 (3.3%) | 1/91 (1.1%) |
| Dalbavancin Two-dose | 0/78 (0%) | 0/78 (0%) | 5/78 (6.4%) |
| Comparator | 0/30 (0%) | 0/30 (0%) | 1/30 (3.3%) |
| Event | Dalbavancin Single-dose | Dalbavancin Two-dose | Comparator |
|---|---|---|---|
| ABSCESS BACTERIALInfections and infestations | 1/91 | 0/78 | 0/30 |
| OSTEOMYELITIS BACTERIALInfections and infestations | 1/91 | 0/78 | 0/30 |
| FEBRILE CONVULSIONNervous system disorders | 1/91 | 0/78 | 0/30 |
| Event | Dalbavancin Single-dose | Dalbavancin Two-dose | Comparator |
|---|---|---|---|
| NASOPHARYNGITISInfections and infestations | 1/91 | 0/78 | 1/30 |
| ANAEMIA POSTOPERATIVEInjury, poisoning and procedural complications | 0/91 | 1/78 | 1/30 |
| VOMITINGGastrointestinal disorders | 0/91 | 2/78 | 0/30 |
| PYREXIAGeneral disorders | 0/91 | 2/78 | 0/30 |
| COUGHRespiratory, thoracic and mediastinal disorders | 0/91 | 2/78 | 0/30 |
Safety population: all participants in the ITT population who received at least 1 dose of study drug
| Age, Continuous(years) | Dalbavancin Single-dose | Dalbavancin Two-dose | Comparator | Total |
|---|---|---|---|---|
| Mean | 7.591 ± 5.4767 | 8.898 ± 4.9271 | 6.775 ± 4.2048 | 7.980 ± 5.1270 |
| Age, Customized(Participants) | Dalbavancin Single-dose | Dalbavancin Two-dose | Comparator | Total |
|---|---|---|---|---|
| Birth to < 3 months (Cohort 5) | 10 | 0 | 0 | 10 |
| 3 months to < 2 years old (Cohort 4) | 9 | 8 | 3 | 20 |
| 2 years to < 6 years old (Cohort 3) | 18 | 17 | 10 | 45 |
| 6 years to < 12 years old (Cohort 2) | 25 | 24 | 11 | 60 |
| 12 years to 17 years old (Cohort 1) | 29 | 29 | 6 | 64 |
| Sex: Female, Male(Participants) | Dalbavancin Single-dose | Dalbavancin Two-dose | Comparator | Total |
|---|---|---|---|---|
| Female | 38 | 25 | 12 | 75 |
| Male | 53 | 53 | 18 | 124 |
| Ethnicity (NIH/OMB)(Participants) | Dalbavancin Single-dose | Dalbavancin Two-dose | Comparator | Total |
|---|---|---|---|---|
| Hispanic or Latino | 6 | 7 | 1 | 14 |
| Not Hispanic or Latino | 85 | 71 | 29 | 185 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Dalbavancin Single-dose | Dalbavancin Two-dose | Comparator | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 5 | 1 | 1 | 7 |
| Asian | 1 | 1 | 0 | 2 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 4 | 6 | 0 | 10 |
| White | 78 | 69 | 29 | 176 |
| More than one race | 3 | 1 | 0 | 4 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
Supporting information: Study protocol, Statistical analysis plan, Clinical study report
Time frame: For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
Access criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
Data sharing details ↗ · vivli.org
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Studies of the drug tested here: Dalbavancin
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