A Phase 3 interventional study of Delafloxacin and Vancomycin in Surgical Site Infection, sponsored by Menarini Group. Terminated at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-02-02.
Sponsored by Menarini Group · Phase 3, Interventional, and Treatment
The purpose of this study is to assess the efficacy and safety of delafloxacin administered as IV and oral formulation in comparison with Best Available Therapy (BAT) in patients with superficial or deep incisional surgical site infection following a cardiothoracic/related leg or abdominal surgery.
This is a randomized, observer-blinded, active-controlled, parallel-group, multicenter, phase IIIb study for the treatment of incisional, superficial or deep, surgical site infection after cardiothoracic /related leg or abdominal surgery (i.e patients who are at risk of microbiologically resistant infections). IV to be switched to oral delafloxacin will be compared to treatments that represent the best available therapy (BAT) for either cardiothoracic/related leg or abdominal surgical site infection (SSI).
Approximately 600 male and female eligible patients will be randomly assigned in a 1:1 ratio to receive delafloxacin or BAT. For patients who are randomised to BAT, the investigator will choose one out of two treatments available (two available for the cardiothoracic/related leg and two available for abdominal SSI) as most appropriate for patient characteristics and local epidemiological pattern.
Duration of study depends on treatment duration (range: minimum 5 to maximum 14 days, as per Investigator's judgment) followed by visits up to 30 days after end of treatment.
Patients will be hospitalized from Screening (within 30 days from surgery) and will remain hospitalized until considered improved or cure as per Investigator's judgment.
745 studies on the registry are indexed under Surgical Wound Infection; 151 are open to participants now.
This study's enrollment of 268 is above the median of 200 across 581 interventional studies indexed under Surgical Wound Infection.
Browse Surgical Wound Infection studies →Menarini Group is the lead sponsor of 28 studies on the registry; 1 is open to participants now.
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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.
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.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
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.
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.
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.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
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.
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.
Delafloxacin IV, with the option to switch to delafloxacin oral
Drug: Delafloxacin
Cardiothoracic / related leg SSI * Vancomycin IV * Linezolid IV, with the option to switch to linezolid oral. In case of suspicion of Gram-negative, additional therapy shall be added as per investigator's choice Abdominal SSI * Piperacillin/Tazobactam IV, OR * Tigecycline IV In case of suspicion of MRSA, if the pre-selected treatment is Piperacillin/Tazobactam, additional therapy shall be added as per investigator's choice.
Drug: Vancomycin · Drug: Linezolid · Drug: Piperacillin/Tazobactam · Drug: Tigecycline
Powder for solution for infusion 300 mg or tablet 450 mg, BID, for 5 to 14 days
Powder for solution for infusion 15mg/kg, BID, for 5 to 14 days
Solution for infusion or tablet, 600 mg BID, for 5 to 14 days
Powder for solution for infusion 4/0.5 g, TID, for 5 to 14 days
Powder for solution for infusion 50 mg, TID, for 5 to 14 days
Number of Participants With Clinical Success at Test Of Cure Visit
Clinical Success defined as the clinical response of "Cure" or "improved". Below the definitions: * Cure: The complete resolution of all baseline signs and symptoms of SSI * Improved: two or more signs and/or symptoms (but not all) were considered resolved thus the patient had improved to an extent that no additional antibiotic treatment was necessary.
Time frame: 7-14 days after last dose
Hospital Infection Related Length of Stay (IRLOS)
Length of Stay since beginning of therapy till patient stabilization and considered suitable for hospital discharge
Time frame: up to 14 days
Hospital Length of Stay (LOS)
Length of Stay since Screening till actual hospital discharge
Time frame: up to 45 days (Late Follow Up visit)
Number of Participants Eligible to Switch to Oral Formulation According to Blinded Observer's Assessment
Blinded assessment based on patient stabilization and ability to tolerate OS diet. In particular, the following details had to be met: Systolic blood pressure normal/not clinically significant abnormal No infection related tachycardia Afebrile status; body temperature \<38°C for at least 24 hours\* WBC count normalized/not clinically significant abnormal Patient able to tolerate PO diet/to take PO treatment and no GI absorption problem The measure counts only the participants eligible to switch, without taking into account the actually switched. Indeed, only linezolid in the BAT has an equivalent oral formulation suitable for the switch.
Time frame: up to 14 days
Microbiological Response
Documented or presumed eradication or persistence
Time frame: up to 14 days (End Of Treatment visit) and 7-14 days after last dose (Test Of Cure visit)
Overall, the recruiment period lasted 13 months, since August 2019 to September 2020. The recruitment was mostly conducted at Abdominal and General surgery departments.
| Milestone | Delafloxacin | Best Available Therapy |
|---|---|---|
| Started | 134 | 132 |
| Vancomycin iv | 0 | 2 |
| Linezolid iv, with the option to switch to linezolid oral | 0 | 8 |
| Piperacillin/tazobactam iv | 0 | 68 |
| Tigecycline iv | 0 | 54 |
| Completed | 127 | 127 |
| Not completed | 7 | 5 |
| Withdrew: Adverse event | 0 | 1 |
| Withdrew: Death | 2 | 1 |
| Withdrew: Physician decision | 2 | 0 |
| Withdrew: Withdrawal by subject | 3 | 2 |
| Withdrew: Lack of efficacy | 0 | 1 |
Clinical Success defined as the clinical response of "Cure" or "improved". Below the definitions: * Cure: The complete resolution of all baseline signs and symptoms of SSI * Improved: two or more signs and/or symptoms (but not all) were considered resolved thus the patient had improved to an extent that no additional antibiotic treatment was necessary.
| Participants | Delafloxacin | Best Available Therapy |
|---|---|---|
| Number of Participants With Clinical Success at Test Of Cure Visit | 123 | 119 |
Length of Stay since beginning of therapy till patient stabilization and considered suitable for hospital discharge
| hours | Delafloxacin | Best Available Therapy |
|---|---|---|
| Hospital Infection Related Length of Stay (IRLOS) | 130.9 ± 71.87 | 140.3 ± 68.98 |
Length of Stay since Screening till actual hospital discharge
| hours | Delafloxacin | Best Available Therapy |
|---|---|---|
| Hospital Length of Stay (LOS) | 178.8 ± 95.44 | 193.5 ± 119.72 |
Blinded assessment based on patient stabilization and ability to tolerate OS diet. In particular, the following details had to be met: Systolic blood pressure normal/not clinically significant abnormal No infection related tachycardia Afebrile status; body temperature \<38°C for at least 24 hours\* WBC count normalized/not clinically significant abnormal Patient able to tolerate PO diet/to take PO treatment and no GI absorption problem The measure counts only the participants eligible to switch, without taking into account the actually switched. Indeed, only linezolid in the BAT has an equivalent oral formulation suitable for the switch.
| Participants | Delafloxacin | Best Available Therapy |
|---|---|---|
| Number of Participants Eligible to Switch to Oral Formulation According to Blinded Observer's Assessment | 129 | 129 |
Documented or presumed eradication or persistence
| Participants | Delafloxacin | Best Available Therapy |
|---|---|---|
| TOC Visit — Eradicated | 94 | 81 |
| TOC Visit — Persisted | 11 | 21 |
| EOT Visit — Eradicated | 80 | 64 |
| EOT Visit — Persisted | 25 | 38 |
Collected over Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.. Non-serious events are listed at a 1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Delafloxacin | 4/134 (3%) | 9/134 (6.7%) | 22/134 (16.4%) |
| Best Available Therapy | 1/132 (0.8%) | 14/132 (10.6%) | 26/132 (19.7%) |
| Linezolid | 0/8 (0%) | 1/8 (12.5%) | 2/8 (25%) |
| Vancomycin | 0/2 (0%) | 0/2 (0%) | 0/2 (0%) |
| Piperacillin/Tazobactam | 0/68 (0%) | 10/68 (14.7%) | 18/68 (26.5%) |
| Tigecycline | 1/54 (1.9%) | 3/54 (5.6%) | 6/54 (11.1%) |
| Event | Delafloxacin | Best Available Therapy | Linezolid | Vancomycin | Piperacillin/Tazobactam | Tigecycline |
|---|---|---|---|---|---|---|
| pleural effusionRespiratory, thoracic and mediastinal disorders | 0/134 | 1/132 | 1/8 | 0/2 | 0/68 | 0/54 |
| deathGeneral disorders | 0/134 | 1/132 | 0/8 | 0/2 | 0/68 | 1/54 |
| wound dehiscenceInjury, poisoning and procedural complications | 0/134 | 1/132 | 0/8 | 0/2 | 0/68 | 1/54 |
| pulmonary embolismRespiratory, thoracic and mediastinal disorders | 1/134 | 2/132 | 0/8 | 0/2 | 1/68 | 1/54 |
| deep vein thrombosisVascular disorders | 1/134 | 1/132 | 0/8 | 0/2 | 0/68 | 1/54 |
| cardiac arrestCardiac disorders | 1/134 | 1/132 | 0/8 | 0/2 | 1/68 | 0/54 |
| enterocutaneous fistulaGastrointestinal disorders | 0/134 | 1/132 | 0/8 | 0/2 | 1/68 | 0/54 |
| intestinal perforationGastrointestinal disorders | 0/134 | 1/132 | 0/8 | 0/2 | 1/68 | 0/54 |
| small intestinal obstructionGastrointestinal disorders | 0/134 | 1/132 | 0/8 | 0/2 | 1/68 | 0/54 |
| malaiseGeneral disorders | 0/134 | 1/132 | 0/8 | 0/2 | 1/68 | 0/54 |
| Event | Delafloxacin | Best Available Therapy | Linezolid | Vancomycin | Piperacillin/Tazobactam | Tigecycline |
|---|---|---|---|---|---|---|
| urinary tract infectionInfections and infestations | 1/134 | 1/132 | 1/8 | 0/2 | 0/68 | 0/54 |
| Blood potassium decreasedInvestigations | 0/134 | 1/132 | 1/8 | 0/2 | 0/68 | 0/54 |
| diarrhoeaGastrointestinal disorders | 3/134 | 3/132 | 0/8 | 0/2 | 1/68 | 2/54 |
| headacheNervous system disorders | 2/134 | 3/132 | 0/8 | 0/2 | 1/68 | 2/54 |
| HypokalaemiaInvestigations | 3/134 | 2/132 | 0/8 | 0/2 | 2/68 | 0/54 |
| hypertensionVascular disorders | 0/134 | 2/132 | 0/8 | 0/2 | 2/68 | 0/54 |
| device related infectionInfections and infestations | 0/134 | 1/132 | 0/8 | 0/2 | 0/68 | 1/54 |
| Blood alkaline phosphatase increasedInvestigations | 0/134 | 1/132 | 0/8 | 0/2 | 0/68 | 1/54 |
| nauseaGastrointestinal disorders | 2/134 | 0/132 | 0/8 | 0/2 | 0/68 | 0/54 |
| pyrexiaGeneral disorders | 2/134 | 1/132 | 0/8 | 0/2 | 1/68 | 0/54 |
ITT analysis population used as reference
| Age, Continuous(years) | Delafloxacin | Best Available Therapy | Total |
|---|---|---|---|
| Mean | 66 ± 13.65 | 63.7 ± 13.71 | 64.9 ± 13.70 |
| Sex: Female, Male(Participants) | Delafloxacin | Best Available Therapy | Total |
|---|---|---|---|
| Female | 61 | 53 | 114 |
| Male | 73 | 79 | 152 |
| Ethnicity (NIH/OMB)(Participants) | Delafloxacin | Best Available Therapy | Total |
|---|---|---|---|
| Hispanic or Latino | 3 | 1 | 4 |
| Not Hispanic or Latino | 131 | 131 | 262 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Delafloxacin | Best Available Therapy | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 1 | 0 | 1 |
| White | 133 | 132 | 265 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Site of infection(Participants) | Delafloxacin | Best Available Therapy | Total |
|---|---|---|---|
| Abdominal SSI | 124 | 122 | 246 |
| Cardiothoracic SSI | 10 | 10 | 20 |
| Depth of infection(Participants) | Delafloxacin | Best Available Therapy | Total |
|---|---|---|---|
| Superficial SSI | 82 | 79 | 161 |
| Deep SSI | 52 | 53 | 105 |
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Sep 2019 to primary completion in Oct 2020, 12 months.
Results were first posted in Oct 2021, 1 year after primary completion.
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Studies of the drug tested here: Delafloxacin