Last updated on May 2019

Phase III Efficacy and Safety Study of AB103 in the Treatment of Patients With Necrotizing Soft Tissue Infections


Brief description of study

The purpose of this study is to determine whether AB103 is safe and effective in the treatment of patients with necrotizing soft tissue infections receiving standard of care therapy.

Detailed Study Description

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:

  • Survival at Day 28
  • Modified SOFA (mSOFA) score on Day 14 and change from baseline to Day 14 3. A Day 14 mSOFA score of 1 and a change from baseline (pre-treatment) to Day 14 3 will be required for a patient to achieve the primary composite clinical success endpoint (NICCE)

Improve the local signs of the infection, as measured by:

  • Reduced number of debridements, counted to Day 14. No more than 3 debridements to Day 14 will be required for a patient to achieve composite clinical success
  • 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.

Clinical Study Identifier: NCT02469857

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Maricopa Medical Center

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Keck Hospital of USC

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Henry Ford Health System

Detroit, MI United States
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Hennepin County Medical Center

Minneapolis, MN United States
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HealthPartners Institute

Saint Paul, MN United States
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University of Missouri

Columbia, MO United States
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St Louis University

Saint Louis, MO United States
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Capital Health System, Inc.

Trenton, NJ United States
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University of New Mexico Hospital

Albuquerque, NM United States
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Albany Medical Center

Albany, NY United States
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Charlotte, NC United States
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East Carolina University

Greenville, NC United States
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The MetroHealth System

Cleveland, OH United States
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The Ohio State University

Columbus, OH United States
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Legacy Emanuel Hospital

Portland, OR United States
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The Trauma Center at PENN

Philadelphia, PA United States
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Thomas Jefferson University

Philadelphia, PA United States
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John Peter Smith Health Network

Fort Worth, TX United States
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Houston Methodist Hospital

Houston, TX United States
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Harborview Medical Center

Seattle, WA United States
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H pital Bic tre

Le Kremlin-Bicêtre, France
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H pital Bic tre

Le Kremlin-Bicêtre, France
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Recruitment Status: Open


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