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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AB103 0.25 mg/kg | Active Comparator |
| |
| AB103 0.5 mg/kg | Active Comparator |
| |
| Placebo | Placebo Comparator | Normal saline (0.9% sodium chloride) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AB103 | Drug | AB103 0.25 mg/kg or 0.5 mg/kg administered as a single IV infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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:
| 28 days |
| Alanine Aminotransferase (ALT) | Screening ALT results, Day 7 ALT results, and change in ALT from screening to Day 7 | Screening and Day 7 |
| Aspartate Aminotransferase (AST) | Screening AST results, Day 7 AST results, and change in AST from screening to Day 7 | Screening and Day 7 |
| Alkaline Phosphatase (ALP) | Screening ALP results, Day 7 ALP results, and change in ALP from screening to Day 7 | Screening and Day 7 |
| Measure | Description | Time Frame |
|---|---|---|
| C-reactive Protein (CRP) | Screening CRP results, Day 7 CRP results, and change in CRP from screening to Day 7 | 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. |
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Inclusion Criteria
Exclusion Criteria
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Southern California Los Angeles | Los Angeles | California | United States | |||
| San Francisco General Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24740134 | Result | Bulger EM, Maier RV, Sperry J, Joshi M, Henry S, Moore FA, Moldawer LL, Demetriades D, Talving P, Schreiber M, Ham B, Cohen M, Opal S, Segalovich I, Maislin G, Kaempfer R, Shirvan A. A Novel Drug for Treatment of Necrotizing Soft-Tissue Infections: A Randomized Clinical Trial. JAMA Surg. 2014 Jun;149(6):528-36. doi: 10.1001/jamasurg.2013.4841. | |
| Result | Bulger EM, Maislin G, Dankner W, May A, Edgar R, Shirvan A. Critical Care Medicine, January 2018,46(1):327. Abstract 682: Early Plasma Cytokine Levels Correlate With Outcome in Necrotizing Soft Tissue Infections. https://journals.lww.com/ccmjournal/Citation/2018/01001/682 |
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Of 43 randomized patients who received AB103 or placebo (intent-to-treat [ITT] population; safety analyses), 3 patients were excluded to form the modified intent-to-treat (mITT) population before unblinding due to protocol violations. Therefore, a total of 40 patients were included in the mITT efficacy analyses. With respect to any variable, the number of patients analyzed is the number of patients with non-missing data within the respective population.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | AB103 0.25 mg/kg | AB103 0.25 mg/kg administered as a single IV infusion |
| FG001 | AB103 0.5 mg/kg | AB103 0.5 mg/kg administered as a single IV infusion |
| Title | Milestones | Reasons Not Completed | ||||
|---|---|---|---|---|---|---|
| Overall Study |
|
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| Placebo | Drug | Normal saline (0.9% sodium chloride) administered as a single IV infusion |
|
| Total Bilirubin (Tbili) |
Screening Tbili results, Day 7 Tbili results, and change in Tbili from screening to Day 7 |
| Screening and Day 7 |
| Serum Creatinine (sCr) | Screening sCr results, Day 7 sCr results, and change in sCr from screening to Day 7 | Screening and Day 7 |
| Albumin (Alb) | Screening Alb results, Day 7 Alb results, and change in Alb from screening to Day 7 | Screening and Day 7 |
| Hemoglobin (Hgb) | Screening Hgb results, Day 7 Hgb results, and change in Hgb from screening to Day 7 | 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 | Screening and Day 7 |
| Platelet (PLT) Count | Screening PLT results, Day 7 PLT results, and change in PLT from screening to Day 7 | 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. | 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 | 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 | 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. | 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) | 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%. | 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. | 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 | 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. |
| 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. | 14 days |
| Hospital Length of Stay (LOS) | The duration of hospital stay over the 28-day study period. | 28 days |
| Intensive Care Unit-free Days (ICU-free Days) | The number of intensive care unit-free days (ICU-free days) | 28 days |
| Ventilator-free Days | The number of ventilator-free days (days without ventilator use) | 28 days |
| San Francisco |
| California |
| United States |
| University of Florida | Gainesville | Florida | United States |
| University of Maryland Medical Center | Baltimore | Maryland | 21201 | United States |
| Oregon Health and Science University | Portland | Oregon | United States |
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15261 | United States |
| Harborview Medical Center | Seattle | Washington | 98104 | United States |
| FG002 | Placebo | Normal saline (0.9% sodium chloride) administered as a single IV infusion |
|
| COMPLETED | ITT Population |
|
| NOT COMPLETED |
|
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.
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| ID | Title | Description |
|---|---|---|
| BG000 | AB103 0.25 mg/kg | AB103 0.25 mg/kg administered as a single IV infusion |
| BG001 | AB103 0.5 mg/kg | AB103 0.5 mg/kg administered as a single IV infusion |
| BG002 | Placebo | Normal saline (0.9% sodium chloride) administered as a single IV infusion |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| NSTI Diagnosis | Count of Participants | Participants |
| ||||||||||||||||
| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m2 |
| |||||||||||||||
| Acute Physiology And Chronic Health Evaluation II (APACHE II) Score | APACHE II is a severity of illness classification system. It is determined within 24 hours of admission of a patient to an intensive care unit (ICU): an integer score from 0 to 71 is computed based on several measurements (physiologic variables, age, chronic health status). Higher scores correspond to more severe disease and a greater risk of death. | Mean | Standard Deviation | units on a scale |
| ||||||||||||||
| Sequential Organ Failure Assessment (SOFA) Score | 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. | Mean | Standard Deviation | units on a scale |
| ||||||||||||||
| Cardiovascular Organ Failure | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | The safety analysis population consisted of all randomized patients who received study drug (N=43). The number of patients analyzed is the number of patients with non-missing data in this population. | Posted | Count of Participants | Participants | 7 days |
|
|
| ||||||||||||||||||||||||||||||||
| Primary | 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:
| The safety analysis population consisted of all randomized patients who received study drug (N=43). The number of patients analyzed is the number of patients with non-missing data in this population. | Posted | Count of Participants | Participants | 28 days |
| ||||||||||||||||||||||||||||||||||
| Primary | Alanine Aminotransferase (ALT) | Screening ALT results, Day 7 ALT results, and change in ALT from screening to Day 7 | The safety analysis population consisted of all randomized patients who received study drug (N=43). The number of patients analyzed is the number of patients with non-missing data in this population. | Posted | Mean | Standard Deviation | units/L | Screening and Day 7 |
|
| ||||||||||||||||||||||||||||||||
| Primary | Aspartate Aminotransferase (AST) | Screening AST results, Day 7 AST results, and change in AST from screening to Day 7 | The safety analysis population consisted of all randomized patients who received study drug (N=43). The number of patients analyzed is the number of patients with non-missing data in this population. | Posted | Mean | Standard Deviation | units/L | Screening and Day 7 |
|
| ||||||||||||||||||||||||||||||||
| Primary | Alkaline Phosphatase (ALP) | Screening ALP results, Day 7 ALP results, and change in ALP from screening to Day 7 | The safety analysis population consisted of all randomized patients who received study drug (N=43). The number of patients analyzed is the number of patients with non-missing data in this population. | Posted | Mean | Standard Deviation | units/L | Screening and Day 7 |
|
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| Primary | Total Bilirubin (Tbili) | Screening Tbili results, Day 7 Tbili results, and change in Tbili from screening to Day 7 | The safety analysis population consisted of all randomized patients who received study drug (N=43). The number of patients analyzed is the number of patients with non-missing data in this population. | Posted | Mean | Standard Deviation | mg/dL | Screening and Day 7 |
|
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| Primary | Serum Creatinine (sCr) | Screening sCr results, Day 7 sCr results, and change in sCr from screening to Day 7 | The safety analysis population consisted of all randomized patients who received study drug (N=43). The number of patients analyzed is the number of patients with non-missing data in this population. | Posted | Mean | Standard Deviation | mg/dL | Screening and Day 7 |
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| Primary | Albumin (Alb) | Screening Alb results, Day 7 Alb results, and change in Alb from screening to Day 7 | The safety analysis population consisted of all randomized patients who received study drug (N=43). The number of patients analyzed is the number of patients with non-missing data in this population. | Posted | Mean | Standard Deviation | g/dL | Screening and Day 7 |
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| Primary | Hemoglobin (Hgb) | Screening Hgb results, Day 7 Hgb results, and change in Hgb from screening to Day 7 | The safety analysis population consisted of all randomized patients who received study drug (N=43). The number of patients analyzed is the number of patients with non-missing data in this population. | Posted | Mean | Standard Deviation | g/dL | Screening and Day 7 |
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| Primary | Total White Blood Cell (WBC) Count | Screening WBC results, Day 7 WBC results, and change in WBC from screening to Day 7 | The safety analysis population consisted of all randomized patients who received study drug (N=43). The number of patients analyzed is the number of patients with non-missing data in this population. | Posted | Mean | Standard Deviation | thousand cells per microliter | Screening and Day 7 |
|
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| Primary | Platelet (PLT) Count | Screening PLT results, Day 7 PLT results, and change in PLT from screening to Day 7 | The safety analysis population consisted of all randomized patients who received study drug (N=43). The number of patients analyzed is the number of patients with non-missing data in this population. | Posted | Mean | Standard Deviation | thousand cells per microliter | Screening and Day 7 |
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| Primary | 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. | The safety analysis population consisted of all randomized patients who received study drug. One of the 0.25 mg/kg patients did not have a Screening INR result. Participant numbers in some rows differ from the overall number analyzed due to missing data as conveyed in the number of participants in each treatment group within a row. | Posted | Mean | Standard Deviation | unitless | Screening and Day 7 |
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| Primary | QT Interval With Fridericia's Correction (QTcF) | Pre-dose QTcF, post-dose QTcF, change in QTcF from pre-dose to post-dose | Safety population: all randomized patients who received study drug. The number of patients analyzed is the number of patients with non-missing data as noted in results. | Posted | Mean | Standard Deviation | msec | Pre-dose and up to 24 hours post-dose |
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| Primary | 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 | Safety population: all randomized patients who received study drug. The number of patients analyzed is the number of patients with non-missing data as noted in results. | Posted | Count of Participants | Participants | Pre-dose and up to 24 hours post-dose |
|
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| Primary | 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. | The pharmacokinetic (PK) analysis population consisted of all intent-to-treat (ITT) patients who received study drug and had a baseline and at least one post-baseline specified plasma sample obtained for quantitative analysis. The number of subjects analyzed reflects the number of subjects for which the parameter could be determined. | Posted | Median | Full Range | ng*min/mL | 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. |
|
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| Primary | Maximum Plasma Concentration (Cmax) | Maximum plasma concentration (observed) | The pharmacokinetic (PK) analysis population consisted of all intent-to-treat (ITT) patients who received study drug and had a baseline and at least one post-baseline specified plasma sample obtained for quantitative analysis. The number of subjects analyzed reflects the number of subjects for which the parameter could be determined. | Posted | Median | Full Range | ng/mL | 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. |
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| Primary | 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%. | The pharmacokinetic (PK) analysis population consisted of all intent-to-treat (ITT) patients who received study drug and had a baseline and at least one post-baseline specified plasma sample obtained for quantitative analysis. The number of subjects analyzed reflects the number of subjects for which the parameter could be determined. | Posted | Median | Full Range | minutes | 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. |
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| Primary | Clearance (CL) | Clearance (CL) is the volume of plasma completely cleared of drug per unit of time. | The pharmacokinetic (PK) analysis population consisted of all intent-to-treat (ITT) patients who received study drug and had a baseline and at least one post-baseline specified plasma sample obtained for quantitative analysis. The number of subjects analyzed reflects the number of subjects for which the parameter could be determined. | Posted | Median | Full Range | mL/min/kg | 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. |
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| Primary | Apparent Volume of Distribution Under Steady State Conditions (Vss) | Apparent volume of distribution under steady state conditions (Vss) based on drug concentration in plasma | The pharmacokinetic (PK) analysis population consisted of all intent-to-treat (ITT) patients who received study drug and had a baseline and at least one post-baseline specified plasma sample obtained for quantitative analysis. The number of subjects analyzed reflects the number of subjects for which the parameter could be determined. | Posted | Median | Full Range | mL/kg | 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. |
|
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| Secondary | C-reactive Protein (CRP) | Screening CRP results, Day 7 CRP results, and change in CRP from screening to Day 7 | The population is all randomized patients who received study drug. The number of patients analyzed is the number of patients with non-missing data in this population. | Posted | Mean | Standard Deviation | mg/dL | Screening and Day 7 |
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| Secondary | 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. | Modified intent-to-treat (mITT) population: all randomized patients who received the proper study drug (AB103 or Placebo), had a definitive surgical diagnosis of NSTI, were not mis-dosed, and did not have a CD4 count <200 cells/mm3. Proper study drug administration meant that study drug administration did not deviate from the planned administration. | Posted | Mean | Standard Deviation | score on a scale | 14 days |
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| Secondary | 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. | Modified intent-to-treat (mITT) population: all randomized patients who received the proper study drug (AB103 or Placebo), had a definitive surgical diagnosis of NSTI, were not mis-dosed, and did not have a CD4 count <200 cells/mm3. Proper study drug administration meant that study drug administration did not deviate from the planned administration. | Posted | Count of Participants | Participants | 14 days |
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| Secondary | Hospital Length of Stay (LOS) | The duration of hospital stay over the 28-day study period. | Modified intent-to-treat (mITT) population: all randomized patients who received the proper study drug (AB103 or Placebo), had a definitive surgical diagnosis of NSTI, were not mis-dosed, and did not have a CD4 count <200 cells/mm3. Proper study drug administration meant that study drug administration did not deviate from the planned administration. The number of patients analyzed is the number of patients with non-missing data in this population. | Posted | Mean | Standard Deviation | days | 28 days |
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| Secondary | Intensive Care Unit-free Days (ICU-free Days) | The number of intensive care unit-free days (ICU-free days) | Modified intent-to-treat (mITT) population: all randomized patients who received the proper study drug (AB103 or Placebo), had a definitive surgical diagnosis of NSTI, were not mis-dosed, and did not have a CD4 count <200 cells/mm3. Proper study drug administration meant that study drug administration did not deviate from the planned administration. The number of patients analyzed is the number of patients with non-missing data in this population. | Posted | Mean | Standard Deviation | ICU-free days | 28 days |
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| Secondary | Ventilator-free Days | The number of ventilator-free days (days without ventilator use) | Modified intent-to-treat (mITT) population: all randomized patients who received the proper study drug (AB103 or Placebo), had a definitive surgical diagnosis of NSTI, were not mis-dosed, and did not have a CD4 count <200 cells/mm3. Proper study drug administration meant that study drug administration did not deviate from the planned administration. The number of patients analyzed is the number of patients with non-missing data in this population. | Posted | Mean | Standard Deviation | ventilator-free days | 28 days |
|
|
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.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | AB103 0.25 mg/kg | AB103 0.25 mg/kg administered as a single IV infusion | 1 | 15 | 8 | 15 | 14 | 15 |
| EG001 | AB103 0.5 mg/kg | AB103 0.5 mg/kg administered as a single IV infusion | 1 | 17 | 5 | 17 | 16 | 17 |
| EG002 | Placebo | Normal saline (0.9% sodium chloride) administered as a single IV infusion | 2 | 11 | 4 | 11 | 9 | 11 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypotension | Cardiac disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Pulmonary edema | Respiratory, thoracic and mediastinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Gastrointestinal hemorrhage | Gastrointestinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA (14.0) | Systematic Assessment |
| |
| Transfusion reaction | Injury, poisoning and procedural complications | MedDRA (14.0) | Systematic Assessment |
| |
| Metabolic acidosis | Metabolism and nutrition disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Multi-organ failure | General disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Withdrawal of life support | Surgical and medical procedures | MedDRA (14.0) | Systematic Assessment |
| |
| Renal failure acute | Renal and urinary disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (14.0) | Systematic Assessment |
| |
| Acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Wound infection | Infections and infestations | MedDRA (14.0) | Systematic Assessment |
| |
| Operative hemorrhage | Injury, poisoning and procedural complications | MedDRA (14.0) | Systematic Assessment |
| |
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Finger amputation | Surgical and medical procedures | MedDRA (14.0) | Systematic Assessment |
| |
| Endotracheal intubation complication | Injury, poisoning and procedural complications | MedDRA (14.0) | Systematic Assessment |
| |
| Wound complication | Injury, poisoning and procedural complications | MedDRA (14.0) | Systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Acute lung injury | Respiratory, thoracic and mediastinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Supraventricular tachycardia | Cardiac disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Fungemia | Infections and infestations | MedDRA (14.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Thrombocytosis | Blood and lymphatic system disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Arrhythmia | Cardiac disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Extrasystoles | Cardiac disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Sinus bradycardia | Cardiac disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Supraventricular tachycardia | Cardiac disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Adrenal insufficiency | Endocrine disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Colonic pseudo-obstruction | Gastrointestinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Gastrointestinal hemorrhage | Gastrointestinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Upper gastrointestinal hemorrhage | Gastrointestinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Face edema | General disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Generalized edema | General disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Localized edema | General disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Multi-organ failure | General disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Edema peripheral | General disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Hepatic failure | Hepatobiliary disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA (14.0) | Systematic Assessment |
| |
| Fungemia | Infections and infestations | MedDRA (14.0) | Systematic Assessment |
| |
| Osteomyelitis | Infections and infestations | MedDRA (14.0) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (14.0) | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA (14.0) | Systematic Assessment |
| |
| Soft tissue infection | Infections and infestations | MedDRA (14.0) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (14.0) | Systematic Assessment |
| |
| Wound infection | Infections and infestations | MedDRA (14.0) | Systematic Assessment |
| |
| Endotracheal intubation complication | Injury, poisoning and procedural complications | MedDRA (14.0) | Systematic Assessment |
| |
| Operative hemorrhage | Injury, poisoning and procedural complications | MedDRA (14.0) | Systematic Assessment |
| |
| Post procedural hemorrhage | Injury, poisoning and procedural complications | MedDRA (14.0) | Systematic Assessment |
| |
| Procedural complication | Injury, poisoning and procedural complications | MedDRA (14.0) | Systematic Assessment |
| |
| Transfusion reaction | Injury, poisoning and procedural complications | MedDRA (14.0) | Systematic Assessment |
| |
| Wound complication | Injury, poisoning and procedural complications | MedDRA (14.0) | Systematic Assessment |
| |
| Wound hemorrhage | Injury, poisoning and procedural complications | MedDRA (14.0) | Systematic Assessment |
| |
| Blood | Investigations | MedDRA (14.0) | Systematic Assessment |
| |
| Blood albumin decreased | Investigations | MedDRA (14.0) | Systematic Assessment |
| |
| Blood bicarbonate decreased | Investigations | MedDRA (14.0) | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA (14.0) | Systematic Assessment |
| |
| Blood calcium decreased | Investigations | MedDRA (14.0) | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA (14.0) | Systematic Assessment |
| |
| Blood glucose increased | Investigations | MedDRA (14.0) | Systematic Assessment |
| |
| Blood magnesium decreased | Investigations | MedDRA (14.0) | Systematic Assessment |
| |
| Blood phosphorus decreased | Investigations | MedDRA (14.0) | Systematic Assessment |
| |
| Blood potassium decreased | Investigations | MedDRA (14.0) | Systematic Assessment |
| |
| Blood pressure increased | Investigations | MedDRA (14.0) | Systematic Assessment |
| |
| Blood sodium decreased | Investigations | MedDRA (14.0) | Systematic Assessment |
| |
| Blood urine present | Investigations | MedDRA (14.0) | Systematic Assessment |
| |
| Body temperature increased | Investigations | MedDRA (14.0) | Systematic Assessment |
| |
| Clostridium test positive | Investigations | MedDRA (14.0) | Systematic Assessment |
| |
| Electrocardiogram QT prolonged | Investigations | MedDRA (14.0) | Systematic Assessment |
| |
| Hematocrit decreased | Investigations | MedDRA (14.0) | Systematic Assessment |
| |
| Haptoglobin increased | Investigations | MedDRA (14.0) | Systematic Assessment |
| |
| International normalized ratio abnormal | Investigations | MedDRA (14.0) | Systematic Assessment |
| |
| International normalized ratio increased | Investigations | MedDRA (14.0) | Systematic Assessment |
| |
| Urine output decreased | Investigations | MedDRA (14.0) | Systematic Assessment |
| |
| Electrolyte imbalance | Metabolism and nutrition disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Fluid overload | Metabolism and nutrition disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Hyperglycemia | Metabolism and nutrition disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Hyperkalemia | Metabolism and nutrition disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Hyperphosphatemia | Metabolism and nutrition disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Hypoalbuminemia | Metabolism and nutrition disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Hypocalcemia | Metabolism and nutrition disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Hypokalemia | Metabolism and nutrition disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Hypomagnesemia | Metabolism and nutrition disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Hyponatremia | Metabolism and nutrition disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Hypophosphatemia | Metabolism and nutrition disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Metabolic acidosis | Metabolism and nutrition disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Lethargy | Nervous system disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Agitation | Psychiatric disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Delirium | Psychiatric disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Oliguria | Renal and urinary disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Renal failure acute | Renal and urinary disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Acute lung injury | Respiratory, thoracic and mediastinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Atelectasis | Respiratory, thoracic and mediastinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Pulmonary edema | Respiratory, thoracic and mediastinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Hyperkeratosis | Skin and subcutaneous tissue disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Pruritis | Skin and subcutaneous tissue disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Skin disorder | Skin and subcutaneous tissue disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Finger amputation | Surgical and medical procedures | MedDRA (14.0) | Systematic Assessment |
| |
| Withdrawal of life support | Surgical and medical procedures | MedDRA (14.0) | Systematic Assessment |
| |
| Arterial hemorrhage | Vascular disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (14.0) | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Wayne M Dankner, MD, Chief Medical Officer | Atox Bio, Ltd. | 1 919-219-6377 | wayned@atoxbio.com |
| ID | Term |
|---|---|
| C000597133 | AB103 |
Not provided
Not provided
Not provided
| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Other NSTI |
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