A Phase 3 interventional study of AB103 0.5 mg/kg and NaCl 0.9% in Necrotizing Soft Tissue Infections, Necrotizing Fasciitis and Fournier's Gangrene, sponsored by Atox Bio Ltd. Completed at 71 sites in 2 countries. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2021-10-05.
Sponsored by Atox Bio Ltd · Phase 3, Interventional, and Treatment
The purpose of this study is to determine whether AB103 is safe and effective in the treatment of patients with necrotizing soft tissue infections (NSTI) receiving standard of care therapy.
The primary hypothesis of this study is that in addition to standard of care treatment (which includes surgical intervention, antimicrobial therapy and critical care support for organ dysfunction or failure), AB103 will demonstrate a clinically significant treatment benefit over placebo.
This hypothesis will be addressed by measuring the effect of AB103 on a composite of clinical parameters associated with the disease course of patients with NSTI, using a responder analysis. A responding patient must meet all 5 parameters of the composite clinical success end point, while a non-responding patient can fail by not meeting any one of the parameters. These analyses are designed to demonstrate that in addition to being safe, one dose of 0.5 mg/kg of AB103 will:
Improve systemic signs of the infection by improving organ function of patients compared to placebo as measured by:
Improve the local signs of the infection, as measured by:
No amputation after the first debridement (amputation on the first debridement is not considered a failure). A patient will be required to have had no amputations done after the first surgical procedure in order to achieve composite clinical success.
290 patients will be recruited into the study and randomized to receive either 0.5 mg/kg AB103 or placebo in a 1:1 ratio. Randomization will be stratified within center by the diagnosis of Fournier's Gangrene and mSOFA score category (3-4 vs >4) at screening. The study will be conducted with interim analyses for futility at 100 patients and safety monitored by an independent Data Monitoring Board at regular planned intervals.
28 studies on the registry are indexed under Fasciitis, Necrotizing; 8 are open to participants now.
This study's enrollment of 290 is above the median of 74 across 12 interventional studies indexed under Fasciitis, Necrotizing.
Browse Fasciitis, Necrotizing studies →Atox Bio Ltd is the lead sponsor of 4 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
Any concurrent medical condition, which in the opinion of the Investigator, may compromise the safety of the patient or the objectives of the study or the patient will not benefit from treatment such as:
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.
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.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
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.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
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 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.
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.
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.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
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.
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.
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.
AB103 0.5 mg/kg, IV, single dose
Drug: AB103 0.5 mg/kg
NaCl 0.9%, IV, single dose
Other: NaCl 0.9%
Drug page: AB103
Also known as: reltecimod
Also known as: Normal saline
Number of Patients Achieving Necrotizing Infections Clinical Composite Endpoint (NICCE)
NICCE was made up of the following 5 components, all of which had to be met to successfully achieve the primary outcome measure (i.e., a "responder"): (i) Alive at Day 28, (ii) ≤ 3 debridements through Day 14, (iii) No amputation performed after the first debridement, (iv) Day 14 modified Sequential Organ Failure Assessment (mSOFA) score ≤ 1, and (v) Reduction of ≥ 3 mSOFA score points between Baseline and Day 14. This analysis compared responders in the reltecimod group versus responders in the placebo group. Modified Sequential Organ Failure Assessment (mSOFA) total scores range from 0 to 20, with higher scores reflecting a worse clinical status or outcome. An mSOFA total score of 0 or 1 reflects resolution of organ dysfunction/failure.
Time frame: 28 days
Number of Patients With One or More Adverse Events (AEs)
Number of Patients With One or More Adverse Events (AEs). Serious Adverse Events (SAEs) are included in this outcome measure since SAEs are a subset of AEs.
Time frame: 28 days
Number of Patients With One or More Serious Adverse Events (SAEs)
Number of Patients with One or More Serious Adverse Events (SAEs) During the Study
Time frame: 28 days
Number of Patients With One or More Secondary Infections
Number of Patients with One or More Secondary Infections During the Study
Time frame: 28 days
Number of Patients Achieving Day 14 Modified Sequential Organ Failure Assessment (mSOFA) Score of 0 or 1
Modified Sequential Organ Failure Assessment (mSOFA) total scores range from 0 to 20, with higher scores reflecting a worse clinical status or outcome. An mSOFA total score of 0 or 1 reflects resolution of organ dysfunction/failure.
Time frame: 14 days
Intensive Care Unit (ICU)-Free Days
ICU-free days refers to the number of days a patient did not spend time in the ICU through Day 28.
Time frame: 28 days
Ventilator-free Days
Ventilator-free days refers to the number of days a patient was not on a ventilator through Day 28.
Time frame: 28 days
Vasopressor-free Days
Vasopressor-free days refers to the number of days a patient did not receive a vasopressor through Day 28.
Time frame: 28 days
Hospital Days
Hospital days refers to the number of days a patient spent time in the hospital.
Time frame: 90 days or until end of follow up
Number of Patients With a More Favorable or Less Favorable Hospital Discharge Location
Number of patients with more favorable discharge location (home or rehabilitation facility) or less favorable discharge location (skilled nursing facility, another acute care facility, death, other)
Time frame: 90 days
Number of Deaths From Day 0 Through Day 90
The number of deaths occurring from Study Day 0 through Study Day 90
Time frame: 90 days
Number of Deaths After Day 14 Through Day 90
Number of deaths after Study Day 14 through Study Day 90
Time frame: 76 days (after Day 14 through Day 90)
Number of Deaths From Day 0 Through Day 90 Among Patients With a Screening mSOFA Score of at Least 5
Number and percentage of patients with a Screening mSOFA score of at least 5 who were alive on Study Day 0 and subsequently died through Study Day 90.
Time frame: 90 days
Number of Deaths After Day 14 Through Day 90 Among Patients With a Screening mSOFA Score of at Least 5
Number and percentage of patients with a Screening mSOFA score of at least 5 who were alive on Study Day 14 and subsequently died through Study Day 90.
Time frame: 76 days (after Day 14 through Day 90)
Number of Deaths From Day 0 Through Day 90 Among Patients With Baseline Cardiovascular Failure (Shock)
Number and percentage of patients with baseline cardiovascular failure (shock) who died through Study Day 90.
Time frame: 90 days
Number of Deaths After Day 14 Through Day 90 Among Patients With Baseline Cardiovascular Failure (Shock)
Number and percentage of patients with baseline cardiovascular failure (shock) who were alive on Study Day 14 and subsequently died through Study Day 90.
Time frame: 76 days (after Day 14 through Day 90)
Number of Patients With a Screening Modified Sequential Organ Failure Assessment (mSOFA) Score of at Least 5 Who Achieved NICCE
NICCE was made up of the following 5 components, all of which had to be met to successfully achieve the primary outcome measure: (i) Alive at Day 28, (ii) ≤ 3 debridements through Day 14, (iii) No amputation performed after the first debridement, (iv) Day 14 modified Sequential Organ Failure Assessment (mSOFA) score ≤ 1, and (v) Reduction of ≥ 3 mSOFA score points between Baseline and Day 14. Modified Sequential Organ Failure Assessment (mSOFA) total scores range from 0 to 20, with higher scores reflecting a worse clinical status or outcome. An mSOFA total score of 0 or 1 reflects resolution of organ dysfunction/failure.
Time frame: 28 days
Number of Patients With a Screening mSOFA Score of at Least 5 Who Achieved Day 14 Modified Sequential Organ Failure Assessment (mSOFA) Score of 0 or 1
Modified Sequential Organ Failure Assessment (mSOFA) total scores range from 0 to 20, with higher scores reflecting a worse clinical status or outcome. An mSOFA total score of 0 or 1 reflects resolution of organ dysfunction/failure.
Time frame: 14 days
Number of Patients With Baseline Cardiovascular Failure (Shock) Who Achieved NICCE
NICCE was made up of the following 5 components, all of which had to be met to successfully achieve the primary outcome measure: (i) Alive at Day 28, (ii) ≤ 3 debridements through Day 14, (iii) No amputation performed after the first debridement, (iv) Day 14 modified Sequential Organ Failure Assessment (mSOFA) score ≤ 1, and (v) Reduction of ≥ 3 mSOFA score points between Baseline and Day 14.
Time frame: 28 days
Number of Patients With Baseline Cardiovascular Failure (Shock) Who Achieved Day 14 Modified Sequential Organ Failure Assessment (mSOFA) Score of 0 or 1
Modified Sequential Organ Failure Assessment (mSOFA) total scores range from 0 to 20, with higher scores reflecting a worse clinical status or outcome. An mSOFA total score of 0 or 1 reflects resolution of organ dysfunction/failure.
Time frame: 14 days
| Milestone | Reltecimod (AB103) 0.5 mg/kg | Placebo |
|---|---|---|
| Started | 143 | 147 |
| Completed | 118 | 115 |
| Not completed | 25 | 32 |
| Withdrew: Death | 24 | 29 |
| Withdrew: Discontinuation | 1 | 3 |
NICCE was made up of the following 5 components, all of which had to be met to successfully achieve the primary outcome measure (i.e., a "responder"): (i) Alive at Day 28, (ii) ≤ 3 debridements through Day 14, (iii) No amputation performed after the first debridement, (iv) Day 14 modified Sequential Organ Failure Assessment (mSOFA) score ≤ 1, and (v) Reduction of ≥ 3 mSOFA score points between Baseline and Day 14. This analysis compared responders in the reltecimod group versus responders in the placebo group. Modified Sequential Organ Failure Assessment (mSOFA) total scores range from 0 to 20, with higher scores reflecting a worse clinical status or outcome. An mSOFA total score of 0 or 1 reflects resolution of organ dysfunction/failure.
| Participants | Reltecimod (AB103) 0.5 mg/kg | Placebo |
|---|---|---|
| mITT Population | 69 | 59 |
| US-mITT Population | 67 | 50 |
Number of Patients With One or More Adverse Events (AEs). Serious Adverse Events (SAEs) are included in this outcome measure since SAEs are a subset of AEs.
| Participants | AB103 0.5 mg/kg | Placebo |
|---|---|---|
| Number of Patients With One or More Adverse Events (AEs) | 104 | 96 |
Number of Patients with One or More Serious Adverse Events (SAEs) During the Study
| Participants | AB103 0.5 mg/kg | Placebo |
|---|---|---|
| Number of Patients With One or More Serious Adverse Events (SAEs) | 44 | 40 |
Number of Patients with One or More Secondary Infections During the Study
| Participants | AB103 0.5 mg/kg | Placebo |
|---|---|---|
| Number of Patients With One or More Secondary Infections | 30 | 32 |
Modified Sequential Organ Failure Assessment (mSOFA) total scores range from 0 to 20, with higher scores reflecting a worse clinical status or outcome. An mSOFA total score of 0 or 1 reflects resolution of organ dysfunction/failure.
| Participants | Reltecimod (AB103) 0.5 mg/kg | Placebo |
|---|---|---|
| Number of Patients Achieving Day 14 Modified Sequential Organ Failure Assessment (mSOFA) Score of 0 or 1 | 87 | 74 |
ICU-free days refers to the number of days a patient did not spend time in the ICU through Day 28.
| days | Reltecimod (AB103) 0.5 mg/kg | Placebo |
|---|---|---|
| Intensive Care Unit (ICU)-Free Days | 20.0 (0 to 28) | 18.0 (0 to 28) |
Ventilator-free days refers to the number of days a patient was not on a ventilator through Day 28.
| days | Reltecimod (AB103) 0.5 mg/kg | Placebo |
|---|---|---|
| Ventilator-free Days | 22.0 (0 to 28) | 21.0 (0 to 28) |
Vasopressor-free days refers to the number of days a patient did not receive a vasopressor through Day 28.
| days | Reltecimod (AB103) 0.5 mg/kg | Placebo |
|---|---|---|
| Vasopressor-free Days | 25.0 (0 to 28) | 25.0 (0 to 28) |
Hospital days refers to the number of days a patient spent time in the hospital.
| days | Reltecimod (AB103) 0.5 mg/kg | Placebo |
|---|---|---|
| Hospital Days | 18.0 (1 to 103) | 19.5 (2 to 135) |
Number of patients with more favorable discharge location (home or rehabilitation facility) or less favorable discharge location (skilled nursing facility, another acute care facility, death, other)
| Participants | Reltecimod (AB103) 0.5 mg/kg | Placebo |
|---|---|---|
| More Favorable Discharge Location | 80 | 64 |
| Less Favorable Discharge Location | 55 | 74 |
The number of deaths occurring from Study Day 0 through Study Day 90
| Participants | Reltecimod (AB103) 0.5 mg/kg | Placebo |
|---|---|---|
| Number of Deaths From Day 0 Through Day 90 | 24 | 29 |
Number of deaths after Study Day 14 through Study Day 90
| Participants | Reltecimod (AB103) 0.5 mg/kg | Placebo |
|---|---|---|
| Number of Deaths After Day 14 Through Day 90 | 8 | 15 |
Number and percentage of patients with a Screening mSOFA score of at least 5 who were alive on Study Day 0 and subsequently died through Study Day 90.
| Participants | Reltecimod (AB103) 0.5 mg/kg | Placebo |
|---|---|---|
| Number of Deaths From Day 0 Through Day 90 Among Patients With a Screening mSOFA Score of at Least 5 | 16 | 19 |
Number and percentage of patients with a Screening mSOFA score of at least 5 who were alive on Study Day 14 and subsequently died through Study Day 90.
| Participants | Reltecimod (AB103) 0.5 mg/kg | Placebo |
|---|---|---|
| Number of Deaths After Day 14 Through Day 90 Among Patients With a Screening mSOFA Score of at Least 5 | 3 | 9 |
Number and percentage of patients with baseline cardiovascular failure (shock) who died through Study Day 90.
| Participants | Reltecimod (AB103) 0.5 mg/kg | Placebo |
|---|---|---|
| Number of Deaths From Day 0 Through Day 90 Among Patients With Baseline Cardiovascular Failure (Shock) | 14 | 15 |
Number and percentage of patients with baseline cardiovascular failure (shock) who were alive on Study Day 14 and subsequently died through Study Day 90.
| Participants | Reltecimod (AB103) 0.5 mg/kg | Placebo |
|---|---|---|
| Number of Deaths After Day 14 Through Day 90 Among Patients With Baseline Cardiovascular Failure (Shock) | 2 | 7 |
NICCE was made up of the following 5 components, all of which had to be met to successfully achieve the primary outcome measure: (i) Alive at Day 28, (ii) ≤ 3 debridements through Day 14, (iii) No amputation performed after the first debridement, (iv) Day 14 modified Sequential Organ Failure Assessment (mSOFA) score ≤ 1, and (v) Reduction of ≥ 3 mSOFA score points between Baseline and Day 14. Modified Sequential Organ Failure Assessment (mSOFA) total scores range from 0 to 20, with higher scores reflecting a worse clinical status or outcome. An mSOFA total score of 0 or 1 reflects resolution of organ dysfunction/failure.
| Participants | Reltecimod (AB103) 0.5 mg/kg | Placebo |
|---|---|---|
| Number of Patients With a Screening Modified Sequential Organ Failure Assessment (mSOFA) Score of at Least 5 Who Achieved NICCE | 38 | 25 |
Modified Sequential Organ Failure Assessment (mSOFA) total scores range from 0 to 20, with higher scores reflecting a worse clinical status or outcome. An mSOFA total score of 0 or 1 reflects resolution of organ dysfunction/failure.
| Participants | Reltecimod (AB103) 0.5 mg/kg | Placebo |
|---|---|---|
| Number of Patients With a Screening mSOFA Score of at Least 5 Who Achieved Day 14 Modified Sequential Organ Failure Assessment (mSOFA) Score of 0 or 1 | 45 | 29 |
NICCE was made up of the following 5 components, all of which had to be met to successfully achieve the primary outcome measure: (i) Alive at Day 28, (ii) ≤ 3 debridements through Day 14, (iii) No amputation performed after the first debridement, (iv) Day 14 modified Sequential Organ Failure Assessment (mSOFA) score ≤ 1, and (v) Reduction of ≥ 3 mSOFA score points between Baseline and Day 14.
| Participants | Reltecimod (AB103) 0.5 mg/kg | Placebo |
|---|---|---|
| Number of Patients With Baseline Cardiovascular Failure (Shock) Who Achieved NICCE | 38 | 18 |
Modified Sequential Organ Failure Assessment (mSOFA) total scores range from 0 to 20, with higher scores reflecting a worse clinical status or outcome. An mSOFA total score of 0 or 1 reflects resolution of organ dysfunction/failure.
| Participants | Reltecimod (AB103) 0.5 mg/kg | Placebo |
|---|---|---|
| Number of Patients With Baseline Cardiovascular Failure (Shock) Who Achieved Day 14 Modified Sequential Organ Failure Assessment (mSOFA) Score of 0 or 1 | 48 | 21 |
Collected over Adverse event (AE) data were collected from study drug administration through the Day 28 visit. Data associated with deaths and study drug-related serious adverse events (SAEs) were collected from study drug administration though the Day 90 visit.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Reltecimod (AB103) 0.5 mg/kg | 24/143 (16.8%) | 44/143 (30.8%) | 24/143 (16.8%) |
| Placebo | 29/147 (19.7%) | 40/147 (27.2%) | 25/147 (17%) |
| Event | Reltecimod (AB103) 0.5 mg/kg | Placebo |
|---|---|---|
| Cardiac arrestCardiac disorders | 4/143 | 4/147 |
| Acute kidney injuryRenal and urinary disorders | 4/143 | 2/147 |
| Acute respiratory distress syndromeRespiratory, thoracic and mediastinal disorders | 2/143 | 4/147 |
| Pulseless electrical activityCardiac disorders | 3/143 | 2/147 |
| Necrotizing soft tissue infectionInfections and infestations | 3/143 | 3/147 |
| PneumoniaInfections and infestations | 3/143 | 1/147 |
| Septic shockInfections and infestations | 3/143 | 2/147 |
| Acute myocardial infarctionCardiac disorders | 2/143 | 3/147 |
| Atrial fibrillationCardiac disorders | 2/143 | 3/147 |
| Organ failureGeneral disorders | 2/143 | 2/147 |
| Event | Reltecimod (AB103) 0.5 mg/kg | Placebo |
|---|---|---|
| PneumoniaInfections and infestations | 5/143 | 11/147 |
| AnemiaBlood and lymphatic system disorders | 8/143 | 6/147 |
| Atrial fibrillationCardiac disorders | 7/143 | 8/147 |
| DiarrheaGastrointestinal disorders | 6/143 | 8/147 |
This analysis population (As Treated/Safety Analysis Set) included all randomized patients who were exposed to study drug (reltecimod or placebo), with patients analyzed according to the treatment actually received.
| Age, Continuous(years) | Reltecimod (AB103) 0.5 mg/kg | Placebo | Total |
|---|---|---|---|
| Mean | 53.4 ± 15.3 | 56.3 ± 15.0 | 54.9 ± 15.2 |
| Sex: Female, Male(Participants) | Reltecimod (AB103) 0.5 mg/kg | Placebo | Total |
|---|---|---|---|
| Female | 58 | 59 | 117 |
| Male | 85 | 88 | 173 |
| Ethnicity (NIH/OMB)(Participants) | Reltecimod (AB103) 0.5 mg/kg | Placebo | Total |
|---|---|---|---|
| Hispanic or Latino | 10 | 11 | 21 |
| Not Hispanic or Latino | 131 | 133 | 264 |
| Unknown or Not Reported | 2 | 3 | 5 |
| Race (NIH/OMB)(Participants) | Reltecimod (AB103) 0.5 mg/kg | Placebo | Total |
|---|---|---|---|
| American Indian or Alaska Native | 3 | 2 | 5 |
| Asian | 2 | 0 | 2 |
| Native Hawaiian or Other Pacific Islander | 0 | 1 | 1 |
| Black or African American | 23 | 24 | 47 |
| White | 106 | 110 | 216 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 9 | 10 | 19 |
| Region of Enrollment(participants) | Reltecimod (AB103) 0.5 mg/kg | Placebo | Total |
|---|---|---|---|
| United States | 135 | 138 | 273 |
| France | 8 | 9 | 17 |
| Body Mass Index (BMI)(kg/m^2) | Reltecimod (AB103) 0.5 mg/kg | Placebo | Total |
|---|---|---|---|
| Mean | 31.4 ± 8.3 | 33.7 ± 8.3 | 32.5 ± 8.4 |
| Necrotizing Soft Tissue Infection (NSTI) Diagnosis(Participants) | Reltecimod (AB103) 0.5 mg/kg | Placebo | Total |
|---|---|---|---|
| Necrotizing Fasciitis | 96 | 95 | 191 |
| Fournier's Gangrene | 43 | 40 | 83 |
| Gas Gangrene/Myonecrosis | 1 | 4 | 5 |
| Other NSTI | 3 | 8 | 11 |
| Comorbidities(Participants) | Reltecimod (AB103) 0.5 mg/kg | Placebo | Total |
|---|---|---|---|
| Diabetes | 64 | 59 | 123 |
| Cardiovascular Disease | 37 | 28 | 65 |
| Smoker | 34 | 32 | 66 |
| Alcohol Abuse | 17 | 13 | 30 |
4 further baseline measures are reported on the registry.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
This study is completed, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: AB103
Atox Bio Ltd