A Phase 2 interventional study of AB103 and Placebo in Necrotizing Soft Tissue Infections, sponsored by Atox Bio Ltd. Completed at 7 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-08-18.
Sponsored by Atox Bio Ltd · Phase 2, Interventional, and Treatment
A study to evaluate the safety and pharmacokinetics profile of different doses of AB103 administered to patients diagnosed with Necrotizing Soft Tissue Infections that are scheduled for an urgent surgical intervention as part of their standard of care.
A study to evaluate the safety and pharmacokinetics profile of different doses of AB103 administered to patients diagnosed with Necrotizing Soft Tissue Infections that are scheduled for an urgent surgical intervention as part of their standard of care. The primary study hypothesis is that AB-103 can be administered safely to the patients presenting with Necrotizing Soft Tissue Infections.
Secondary endpoints are efficacy by exploratory descriptive analyses of specific efficacy endpoints from three outcome domains to demonstrate treatment benefit of AB103 in comparison to placebo in patients with Necrotizing Soft Tissue Infections. The efficacy domains are:
92 studies on the registry are indexed under Soft Tissue Infections; 14 are open to participants now.
This study's enrollment of 43 is below the median of 123 across 58 interventional studies indexed under Soft Tissue Infections.
Browse Soft Tissue Infections 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
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Drug: AB103
Drug: AB103
Normal saline (0.9% sodium chloride)
Drug: Placebo
AB103 0.25 mg/kg or 0.5 mg/kg administered as a single IV infusion
Also known as: p2TA
Normal saline (0.9% sodium chloride) administered as a single IV infusion
Number of Subjects With One or More Adverse Events (AEs) During the Treatment Period
An AE is any untoward medical occurrence in a subject administered study drug and that does not necessarily have a causal relationship with the study drug. An AE could therefore be any unfavorable and unintended sign (including abnormal laboratory findings), symptom, or disease temporally associated with the use of the study drug, whether or not considered related to the study drug.
Time frame: 7 days
Number of Subjects With One or More Serious Adverse Events (SAEs)
A serious adverse event (SAE) is an AE occurring during any study phase and at any dose of the study drug (AB103 or placebo) that fulfills one or more of the following criteria: * Results in death * Is life-threatening (i.e., the subject was, in the opinion of the Investigator, at immediate risk of death from the event as it occurred) * Requires or prolongs hospitalization * Results in persistent or significant disability or incapacity (i.e., the event causes a substantial disruption of a person's ability to conduct normal life functions) * Is a congenital anomaly or birth defect, or * Is an important and significant medical event.
Time frame: 28 days
Alanine Aminotransferase (ALT)
Screening ALT results, Day 7 ALT results, and change in ALT from screening to Day 7
Time frame: Screening and Day 7
Aspartate Aminotransferase (AST)
Screening AST results, Day 7 AST results, and change in AST from screening to Day 7
Time frame: Screening and Day 7
Alkaline Phosphatase (ALP)
Screening ALP results, Day 7 ALP results, and change in ALP from screening to Day 7
Time frame: Screening and Day 7
Total Bilirubin (Tbili)
Screening Tbili results, Day 7 Tbili results, and change in Tbili from screening to Day 7
Time frame: Screening and Day 7
Serum Creatinine (sCr)
Screening sCr results, Day 7 sCr results, and change in sCr from screening to Day 7
Time frame: Screening and Day 7
Albumin (Alb)
Screening Alb results, Day 7 Alb results, and change in Alb from screening to Day 7
Time frame: Screening and Day 7
Hemoglobin (Hgb)
Screening Hgb results, Day 7 Hgb results, and change in Hgb from screening to Day 7
Time frame: Screening and Day 7
Total White Blood Cell (WBC) Count
Screening WBC results, Day 7 WBC results, and change in WBC from screening to Day 7
Time frame: Screening and Day 7
Platelet (PLT) Count
Screening PLT results, Day 7 PLT results, and change in PLT from screening to Day 7
Time frame: Screening and Day 7
International Normalized Ratio (INR)
Screening INR results, Day 7 INR results, and change in INR from screening to Day 7. In general, the higher the INR value, the longer it takes for blood to form a clot.
Time frame: Screening and Day 7
QT Interval With Fridericia's Correction (QTcF)
Pre-dose QTcF, post-dose QTcF, change in QTcF from pre-dose to post-dose
Time frame: Pre-dose and up to 24 hours post-dose
Categorical Change in QTcF
Number and percentage of patients with a change in QTcF of \> 30 msec; number and percentage of patients with a change in QTcF of \> 60 msec
Time frame: Pre-dose and up to 24 hours post-dose
Area Under the Plasma Concentration Versus Time Curve (AUC)
Area under the plasma concentration versus time curve (AUC) from time zero to infinity following a single dose of study drug, obtained by noncompartmental methods. It is an integrated measure of study drug plasma exposure.
Time frame: Prior to infusion, at mid infusion time, end of infusion, and at 2, 5, 10, 20, 30, 60 min and 120 minutes after completion of the IV infusion of study drug.
Maximum Plasma Concentration (Cmax)
Maximum plasma concentration (observed)
Time frame: Prior to infusion, at mid infusion time, end of infusion, and at 2, 5, 10, 20, 30, 60 min and 120 minutes after completion of the IV infusion of study drug.
Apparent Terminal Plasma Half-life (T1/2)
Apparent terminal plasma half-life (T1/2) is the amount of time for plasma concentrations to decline by 50%.
Time frame: Prior to infusion, at mid infusion time, end of infusion, and at 2, 5, 10, 20, 30, 60 min and 120 minutes after completion of the IV infusion of study drug.
Clearance (CL)
Clearance (CL) is the volume of plasma completely cleared of drug per unit of time.
Time frame: Prior to infusion, at mid infusion time, end of infusion, and at 2, 5, 10, 20, 30, 60 min and 120 minutes after completion of the IV infusion of study drug.
Apparent Volume of Distribution Under Steady State Conditions (Vss)
Apparent volume of distribution under steady state conditions (Vss) based on drug concentration in plasma
Time frame: Prior to infusion, at mid infusion time, end of infusion, and at 2, 5, 10, 20, 30, 60 min and 120 minutes after completion of the IV infusion of study drug.
C-reactive Protein (CRP)
Screening CRP results, Day 7 CRP results, and change in CRP from screening to Day 7
Time frame: Screening and Day 7
Day 14 Sequential Organ Failure Assessment (SOFA) Score
Day 14 SOFA score is the sum of individual SOFA score components at Day 14. Results include last observation carried forward (LOCF) imputation for missing values. SOFA total scores range from 0 to 24, with higher scores reflecting a worse clinical status or outcome. A SOFA total score of 0 or 1 reflects resolution of organ dysfunction/failure.
Time frame: 14 days
Day 14 Sequential Organ Failure Assessment (SOFA) Score Less Than or Equal to 1
Number and percentage of patients with Day 14 Sequential Organ Failure Assessment (SOFA) score less than or equal to 1. SOFA total scores range from 0 to 24, with higher scores reflecting a worse clinical status or outcome. A SOFA total score of 0 or 1 reflects resolution of organ dysfunction/failure.
Time frame: 14 days
Hospital Length of Stay (LOS)
The duration of hospital stay over the 28-day study period.
Time frame: 28 days
Intensive Care Unit-free Days (ICU-free Days)
The number of intensive care unit-free days (ICU-free days)
Time frame: 28 days
Ventilator-free Days
The number of ventilator-free days (days without ventilator use)
Time frame: 28 days
This study was conducted by qualified investigators under the sponsorship of Atox Bio Ltd. at 7 trauma centers, of which 6 enrolled patients from December 2011 through August 2012.
| Milestone | AB103 0.25 mg/kg | AB103 0.5 mg/kg | Placebo |
|---|---|---|---|
| Started | 15 | 17 | 11 |
| Completed | 14 | 14 | 9 |
| Not completed | 1 | 3 | 2 |
An AE is any untoward medical occurrence in a subject administered study drug and that does not necessarily have a causal relationship with the study drug. An AE could therefore be any unfavorable and unintended sign (including abnormal laboratory findings), symptom, or disease temporally associated with the use of the study drug, whether or not considered related to the study drug.
| Participants | AB103 0.25 mg/kg | AB103 0.5 mg/kg | Placebo |
|---|---|---|---|
| Number of Subjects With One or More Adverse Events (AEs) During the Treatment Period | 14 | 16 | 9 |
A serious adverse event (SAE) is an AE occurring during any study phase and at any dose of the study drug (AB103 or placebo) that fulfills one or more of the following criteria: * Results in death * Is life-threatening (i.e., the subject was, in the opinion of the Investigator, at immediate risk of death from the event as it occurred) * Requires or prolongs hospitalization * Results in persistent or significant disability or incapacity (i.e., the event causes a substantial disruption of a person's ability to conduct normal life functions) * Is a congenital anomaly or birth defect, or * Is an important and significant medical event.
| Participants | AB103 0.25 mg/kg | AB103 0.5 mg/kg | Placebo |
|---|---|---|---|
| Number of Subjects With One or More Serious Adverse Events (SAEs) | 8 | 5 | 4 |
Screening ALT results, Day 7 ALT results, and change in ALT from screening to Day 7
| units/L | AB103 0.25 mg/kg | AB103 0.5 mg/kg | Placebo |
|---|---|---|---|
| Screening | 55.9 ± 99.8 | 28.1 ± 17.3 | 46.8 ± 57.2 |
| Day 7 | 27.9 ± 18.8 | 27.3 ± 26.3 | 26.0 ± 13.2 |
| Change from Screening to Day 7 | -23.2 ± 95.1 | -0.8 ± 31.2 | -19.8 ± 60.5 |
Screening AST results, Day 7 AST results, and change in AST from screening to Day 7
| units/L | AB103 0.25 mg/kg | AB103 0.5 mg/kg | Placebo |
|---|---|---|---|
| Screening | 35.8 ± 30.6 | 37.4 ± 28.3 | 32.0 ± 19.2 |
| Day 7 | 30.6 ± 17.1 | 24.3 ± 10.1 | 27.4 ± 9.7 |
| Change from Screening to Day 7 | -1.2 ± 30.7 | -9.3 ± 21.7 | 0.1 ± 9.6 |
Screening ALP results, Day 7 ALP results, and change in ALP from screening to Day 7
| units/L | AB103 0.25 mg/kg | AB103 0.5 mg/kg | Placebo |
|---|---|---|---|
| Screening | 97.5 ± 53.5 | 104.3 ± 47.7 | 108.3 ± 44.2 |
| Day 7 | 93.1 ± 45.2 | 84.8 ± 33.9 | 100.6 ± 65.9 |
| Change from Screening to Day 7 | 5.2 ± 40.1 | -10.6 ± 62.3 | -11.4 ± 34.6 |
Screening Tbili results, Day 7 Tbili results, and change in Tbili from screening to Day 7
| mg/dL | AB103 0.25 mg/kg | AB103 0.5 mg/kg | Placebo |
|---|---|---|---|
| Screening | 1.2 ± 0.7 | 1.2 ± 0.8 | 1.5 ± 1.7 |
| Day 7 | 0.6 ± 0.2 | 0.6 ± 0.3 | 1.1 ± 0.8 |
| Change from Screening to Day 7 | -0.8 ± 0.6 | -0.5 ± 0.5 | -0.4 ± 1.4 |
Screening sCr results, Day 7 sCr results, and change in sCr from screening to Day 7
| mg/dL | AB103 0.25 mg/kg | AB103 0.5 mg/kg | Placebo |
|---|---|---|---|
| Screening | 1.2 ± 0.5 | 1.2 ± 1.0 | 1.2 ± 0.7 |
| Day 7 | 1.1 ± 0.9 | 1.3 ± 1.7 | 1.0 ± 0.4 |
| Change from Screening to Day 7 | -0.1 ± 0.7 | 0.1 ± 2.0 | -0.2 ± 0.6 |
Screening Alb results, Day 7 Alb results, and change in Alb from screening to Day 7
| g/dL | AB103 0.25 mg/kg | AB103 0.5 mg/kg | Placebo |
|---|---|---|---|
| Screening | 2.5 ± 0.9 | 2.1 ± 0.5 | 2.3 ± 0.5 |
| Day 7 | 1.9 ± 0.9 | 1.7 ± 0.4 | 2.3 ± 0.6 |
| Change from Screening to Day 7 | -0.6 ± 0.4 | -0.3 ± 0.2 | 0.1 ± 0.7 |
Screening Hgb results, Day 7 Hgb results, and change in Hgb from screening to Day 7
| g/dL | AB103 0.25 mg/kg | AB103 0.5 mg/kg | Placebo |
|---|---|---|---|
| Screening | 11.5 ± 2.2 | 11.0 ± 1.5 | 10.5 ± 2.6 |
| Day 7 | 8.8 ± 2.1 | 8.9 ± 1.1 | 9.0 ± 1.4 |
| Change from Screening to Day 7 | -2.9 ± 2.1 | -2.5 ± 1.5 | -1.3 ± 2.4 |
Screening WBC results, Day 7 WBC results, and change in WBC from screening to Day 7
| thousand cells per microliter | AB103 0.25 mg/kg | AB103 0.5 mg/kg | Placebo |
|---|---|---|---|
| Screening | 17.8 ± 10.0 | 14.7 ± 8.8 | 21.7 ± 16.2 |
| Day 7 | 14.3 ± 6.7 | 12.5 ± 5.1 | 12.3 ± 2.4 |
| Change from Screening to Day 7 | -5.0 ± 9.3 | -3.0 ± 10.9 | -11.2 ± 14.9 |
Screening PLT results, Day 7 PLT results, and change in PLT from screening to Day 7
| thousand cells per microliter | AB103 0.25 mg/kg | AB103 0.5 mg/kg | Placebo |
|---|---|---|---|
| Screening | 300.2 ± 182.2 | 215.1 ± 82.0 | 255.3 ± 130.0 |
| Day 7 | 401.5 ± 168.8 | 341.8 ± 140.6 | 318.3 ± 148.2 |
| Change from Screening to Day 7 | 81.8 ± 237.1 | 125.1 ± 144.6 | 49.9 ± 160.2 |
Screening INR results, Day 7 INR results, and change in INR from screening to Day 7. In general, the higher the INR value, the longer it takes for blood to form a clot.
| unitless | AB103 0.25 mg/kg | AB103 0.5 mg/kg | Placebo |
|---|---|---|---|
| Screening | 1.29 ± 0.22 | 1.43 ± 0.33 | 1.41 ± 0.38 |
| Day 7 | 1.2 ± 0.1 | 1.2 ± 0.1 | 1.3 ± 0.3 |
| Change from Screening to Day 7 | -0.1 ± 0.2 | -0.2 ± 0.3 | -0.2 ± 0.3 |
Pre-dose QTcF, post-dose QTcF, change in QTcF from pre-dose to post-dose
| msec | AB103 0.25 mg/kg | AB103 0.5 mg/kg | Placebo |
|---|---|---|---|
| Pre-dose QTcF | 419.1 ± 39.3 | 401.8 ± 16.8 | 405.1 ± 38.6 |
| Post-dose QTcF | 409.2 ± 23.1 | 403.1 ± 39.3 | 407.4 ± 29.6 |
| Change in QTcF from pre-dose to post-dose | -9.9 ± 37.2 | 1.3 ± 36.1 | 8.9 ± 31.0 |
Number and percentage of patients with a change in QTcF of \> 30 msec; number and percentage of patients with a change in QTcF of \> 60 msec
| Participants | AB103 0.25 mg/kg | AB103 0.5 mg/kg | Placebo |
|---|---|---|---|
| Patients with a change in QTcF of > 30 msec | 1 | 3 | 2 |
| Patients with a change in QTcF of > 60 msec | 1 | 2 | 1 |
Area under the plasma concentration versus time curve (AUC) from time zero to infinity following a single dose of study drug, obtained by noncompartmental methods. It is an integrated measure of study drug plasma exposure.
| ng*min/mL | AB103 0.25 mg/kg | AB103 0.5 mg/kg |
|---|---|---|
| Area Under the Plasma Concentration Versus Time Curve (AUC) | 8497 (2836 to 14269) | 16921 (4843 to 28952) |
Maximum plasma concentration (observed)
| ng/mL | AB103 0.25 mg/kg | AB103 0.5 mg/kg |
|---|---|---|
| Maximum Plasma Concentration (Cmax) | 899 (98 to 2664) | 1484 (661 to 3418) |
Apparent terminal plasma half-life (T1/2) is the amount of time for plasma concentrations to decline by 50%.
| minutes | AB103 0.25 mg/kg | AB103 0.5 mg/kg |
|---|---|---|
| Apparent Terminal Plasma Half-life (T1/2) | 2.61 (1.28 to 18.99) | 4.89 (1.53 to 14.16) |
Clearance (CL) is the volume of plasma completely cleared of drug per unit of time.
| mL/min/kg | AB103 0.25 mg/kg | AB103 0.5 mg/kg |
|---|---|---|
| Clearance (CL) | 29.42 (17.52 to 88.14) | 29.55 (17.27 to 103.24) |
Apparent volume of distribution under steady state conditions (Vss) based on drug concentration in plasma
| mL/kg | AB103 0.25 mg/kg | AB103 0.5 mg/kg |
|---|---|---|
| Apparent Volume of Distribution Under Steady State Conditions (Vss) | 100 (53 to 157) | 135 (36 to 318) |
Screening CRP results, Day 7 CRP results, and change in CRP from screening to Day 7
| mg/dL | AB103 0.25 mg/kg | AB103 0.5 mg/kg | Placebo |
|---|---|---|---|
| Screening | 29.2 ± 12.3 | 27.5 ± 6.2 | 20.6 ± 13.2 |
| Day 7 | 11.7 ± 10.0 | 7.5 ± 4.4 | 4.0 ± 3.0 |
| Change from Screening to Day 7 | -19.2 ± 14.6 | -22.7 ± 5.9 | -20.5 ± 11.0 |
Day 14 SOFA score is the sum of individual SOFA score components at Day 14. Results include last observation carried forward (LOCF) imputation for missing values. SOFA total scores range from 0 to 24, with higher scores reflecting a worse clinical status or outcome. A SOFA total score of 0 or 1 reflects resolution of organ dysfunction/failure.
| score on a scale | AB103 0.25 mg/kg | AB103 0.5 mg/kg | Placebo |
|---|---|---|---|
| Day 14 Sequential Organ Failure Assessment (SOFA) Score | 1.07 ± 1.00 | 0.71 ± 0.83 | 2.70 ± 2.79 |
Number and percentage of patients with Day 14 Sequential Organ Failure Assessment (SOFA) score less than or equal to 1. SOFA total scores range from 0 to 24, with higher scores reflecting a worse clinical status or outcome. A SOFA total score of 0 or 1 reflects resolution of organ dysfunction/failure.
| Participants | AB103 0.25 mg/kg | AB103 0.5 mg/kg | Placebo |
|---|---|---|---|
| Day 14 Sequential Organ Failure Assessment (SOFA) Score Less Than or Equal to 1 | 10 | 13 | 4 |
The duration of hospital stay over the 28-day study period.
| days | AB103 0.25 mg/kg | AB103 0.5 mg/kg | Placebo |
|---|---|---|---|
| Hospital Length of Stay (LOS) | 17.1 ± 7.96 | 17.4 ± 9.07 | 20.0 ± 6.93 |
The number of intensive care unit-free days (ICU-free days)
| ICU-free days | AB103 0.25 mg/kg | AB103 0.5 mg/kg | Placebo |
|---|---|---|---|
| Intensive Care Unit-free Days (ICU-free Days) | 21.7 ± 8.48 | 21.3 ± 6.21 | 17.1 ± 9.88 |
The number of ventilator-free days (days without ventilator use)
| ventilator-free days | AB103 0.25 mg/kg | AB103 0.5 mg/kg | Placebo |
|---|---|---|---|
| Ventilator-free Days | 23.5 ± 8.75 | 24.1 ± 6.25 | 20.8 ± 9.14 |
Collected over Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| AB103 0.25 mg/kg | 1/15 (6.7%) | 8/15 (53.3%) | 14/15 (93.3%) |
| AB103 0.5 mg/kg | 1/17 (5.9%) | 5/17 (29.4%) | 16/17 (94.1%) |
| Placebo | 2/11 (18.2%) | 4/11 (36.4%) | 9/11 (81.8%) |
| Event | AB103 0.25 mg/kg | AB103 0.5 mg/kg | Placebo |
|---|---|---|---|
| HypotensionCardiac disorders | 3/15 | 1/17 | 0/11 |
| Respiratory failureRespiratory, thoracic and mediastinal disorders | 2/15 | 3/17 | 1/11 |
| Septic shockInfections and infestations | 0/15 | 1/17 | 1/11 |
| Renal failure acuteRenal and urinary disorders | 1/15 | 1/17 | 1/11 |
| BradycardiaCardiac disorders | 0/15 | 0/17 | 1/11 |
| Cardiac arrestCardiac disorders | 0/15 | 0/17 | 1/11 |
| Pleural effusionRespiratory, thoracic and mediastinal disorders | 0/15 | 0/17 | 1/11 |
| Acute lung injuryRespiratory, thoracic and mediastinal disorders | 0/15 | 0/17 | 1/11 |
| Supraventricular tachycardiaCardiac disorders | 0/15 | 0/17 | 1/11 |
| FungemiaInfections and infestations | 0/15 | 0/17 | 1/11 |
| Event | AB103 0.25 mg/kg | AB103 0.5 mg/kg | Placebo |
|---|---|---|---|
| PyrexiaGeneral disorders | 3/15 | 7/17 | 2/11 |
| Blood phosphorus decreasedInvestigations | 6/15 | 7/17 | 1/11 |
| Blood potassium decreasedInvestigations | 5/15 | 7/17 | 3/11 |
| HypotensionVascular disorders | 3/15 | 3/17 | 4/11 |
| Blood magnesium decreasedInvestigations | 5/15 | 6/17 | 3/11 |
| Hematocrit decreasedInvestigations | 5/15 | 3/17 | 3/11 |
| Metabolic acidosisMetabolism and nutrition disorders | 0/15 | 2/17 | 3/11 |
| HyperglycemiaMetabolism and nutrition disorders | 2/15 | 4/17 | 2/11 |
| ThrombocytopeniaBlood and lymphatic system disorders | 0/15 | 0/17 | 2/11 |
| BradycardiaCardiac disorders | 0/15 | 0/17 | 2/11 |
Data are from the modified intent-to-treat (mITT) population. The mITT population consisted of all randomized patients who received the proper study drug (AB103 or placebo) and dose, had a definitive surgical diagnosis of NSTI, and did not have a CD4 count \<200 cells/mm3.
| Age, Continuous(years) | AB103 0.25 mg/kg | AB103 0.5 mg/kg | Placebo | Total |
|---|---|---|---|---|
| Mean | 46.3 ± 13.6 | 50.1 ± 15.2 | 52.5 ± 20.4 | 50.9 ± 15.2 |
| Sex: Female, Male(Participants) | AB103 0.25 mg/kg | AB103 0.5 mg/kg | Placebo | Total |
|---|---|---|---|---|
| Female | 4 | 6 | 4 | 14 |
| Male | 11 | 9 | 6 | 26 |
| Ethnicity (NIH/OMB)(Participants) | AB103 0.25 mg/kg | AB103 0.5 mg/kg | Placebo | Total |
|---|---|---|---|---|
| Hispanic or Latino | 2 | 1 | 1 | 4 |
| Not Hispanic or Latino | 13 | 14 | 9 | 36 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | AB103 0.25 mg/kg | AB103 0.5 mg/kg | Placebo | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 1 | 1 |
| Asian | 0 | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 1 | 1 | 1 | 3 |
| White | 14 | 14 | 7 | 35 |
| More than one race | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 1 | 1 |
| NSTI Diagnosis(Participants) | AB103 0.25 mg/kg | AB103 0.5 mg/kg | Placebo | Total |
|---|---|---|---|---|
| Fournier Gangrene | 5 | 6 | 2 | 13 |
| Other NSTI | 10 | 9 | 8 | 27 |
| Body Mass Index (BMI)(kg/m2) | AB103 0.25 mg/kg | AB103 0.5 mg/kg | Placebo | Total |
|---|---|---|---|---|
| Mean | 31.0 ± 6.5 | 31.7 ± 9.7 | 29.9 ± 9.3 | 31.5 ± 8.2 |
| Acute Physiology And Chronic Health Evaluation II (APACHE II) Score(units on a scale) | AB103 0.25 mg/kg | AB103 0.5 mg/kg | Placebo | Total |
|---|---|---|---|---|
| Mean | 7.5 ± 5.0 | 8.3 ± 4.5 | 9.6 ± 4.7 | 8.3 ± 4.7 |
| Sequential Organ Failure Assessment (SOFA) Score(units on a scale) | AB103 0.25 mg/kg | AB103 0.5 mg/kg | Placebo | Total |
|---|---|---|---|---|
| Mean | 2.87 ± 2.70 | 3.47 ± 2.53 | 3.10 ± 1.97 | 3.15 ± 2.42 |
1 further baseline measures are reported on the registry.
Plan to share: No
Ran from Dec 2011 to primary completion in Sep 2012, 9 months.
Results were first posted in Aug 2021, 8 years 11 months after primary completion. A results delay was requested in Jan 2021.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 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