Last updated on October 2017

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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Kevin Foster, MD

Maricopa Medical Center
Phoenix, AZ United States
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Gary Vercruysse, MD

Banner University Medical Center
Tucson, AZ United States
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Richard Catalano, MD

Loma Linda University Medical Center
Loma Linda, CA United States
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Kazuhide Matsushima, MD

Keck Hospital of USC
Los Angeles, CA United States
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Kazuhide Matsushima, MD

University of Southern California-LAC+USC Medical Center
Los Angeles, CA United States
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Loren G Miller, MD

Los Angeles Biomedical Research Institute at Harbor UCLA Medical Center
Los Angeles, CA United States
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Michael Lekawa, MD

University of California, Irvine Medical Center
Orange, CA United States
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Christine S Cocanour, MD

University of California, Davis Medical Center
Sacramento, CA United States
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Leslie Kobayashi, MD

UCSD Medical Center
San Diego, CA United States
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Robert McIntyre, MD

University of Colorado Hospital
Denver, CO United States
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Eric Campion, MD

Denver Health Medical Center
Denver, CO United States
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Adrian Maung, MD

Yale New Haven Hospital
New Haven, CT United States
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Wayne M Dankner, MD

Christiana Care Health System
Newark, DE United States
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Jack A Sava, MD

Washington Hospital Center
Washington, D.C., United States
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Scott Brakenridge, MD

UF Health Shands Hospital
Gainesville, FL United States
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Nicholas Namias, MD

Ryder Trauma Center/Jackson Memorial Hospital
Miami, FL United States
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Bounthavy Homsombath, MD

Joseph M. Still Burn Center at Doctors Hospital
Augusta, GA United States
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Wayne M Dankner, MD

Loyola University Medical Center
Maywood, IL United States
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Wayne M Dankner, MD

Indiana University Health Methodist Hospital
Indianapolis, IN United States
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Kent Choi, MD

University of Iowa Hospital and Clinics
Iowa City, IA United States
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Andrew Bernard, MD

University of Kentucky
Lexington, KY United States
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Wayne M Dankner, MD

University of Louisville
Louisville, KY United States
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Hollis O'Neal, MD

Our Lady of the Lake Regional Medical Center
Baton Rouge, LA United States
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Patrick Greiffenstein, MD

LSU Health Science Center
New Orleans, LA United States
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Joseph Rappold, MD

Maine Medical Center
Portland, ME United States
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Sharon Henry, MD

University of Maryland R Adams Cowley Shock Trauma Center
Baltimore, MD United States
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Peter Fagenholz, MD

Massachusetts General Hospital
Boston, MA United States
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Reza Askari, MD

Brigham and Women's Hospital
Boston, MA United States
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Wayne M Dankner, MD

Boston Medical Center
Boston, MA United States
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Pauline Park, MD

University of Michigan
Ann Arbor, MI United States
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Robert Sherwin, MD

Wayne State University-Detroit Receiving Hospital
Detroit, MI United States
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Jeffrey Johnson, MD

Henry Ford Health System
Detroit, MI United States
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Lawrence Diebel, MD

Wayne State University-Sinai Grace Hospital
Detroit, MI United States
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Greg Bielman, MD

University of Minnesota Medical Center-Fairview
Minneapolis, MN United States
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David Dries, MD

HealthPartners Institute
Saint Paul, MN United States
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Jacob Quick, MD

University of Missouri
Columbia, MO United States
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Ju Lin Wang, MD

Cooper University Hospital
Camden, NJ United States
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Howard Yonas, MD

University of New Mexico Hospital
Albuquerque, NM United States
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William Flynn, MD

Erie County Medical Center-Affliate of SUNYat Buffalo
Buffalo, NY United States
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Stephen Cohn, MD

Staten Island University Hospital-Northwell Health
Staten Island, NY United States
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Vance Smith, MD

Montefiore Medical Center-Weiler Division
The Bronx, NY United States
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Vance Smith, MD

Montefiore Medical Center-Moses Division
The Bronx, NY United States
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John Green, MD

Carolinas Medical Center
Charlotte, NC United States
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Eric Toschlog, MD

East Carolina University
Greenville, NC United States
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Timothy Pritts, MD

University of Cincinnati Medical Center (UCMC)
Cincinnati, OH United States
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Jeffrey A Claridge, MD

The MetroHealth System
Cleveland, OH United States
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David Evans, MD

The Ohio State University
Columbus, OH United States
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Peter Ekeh, MD

Wright State University & Premier Health Clinical Trials Research Alliance
Dayton, OH United States
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Wayne M Dankner, MD

University of Toledo Medical Center
Toledo, OH United States
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Gregory Huang, MD

St Elizabeth Youngstown Hospital
Youngstown, OH United States
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Wayne M Dankner, MD

Oklahoma University Health Science Center
Oklahoma City, OK United States
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Wayne M Dankner, MD

Legacy Emanuel Hospital
Portland, OR United States
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Martin Schreiber, MD

Oregon Health and Science University
Portland, OR United States
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John Lukaszczyk, MD

St. Luke's University Health Network
Bethlehem, PA United States
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Niels Martin, MD

The Trauma Center at PENN
Philadelphia, PA United States
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Jason Sperry, MD

University of Pittsburgh Medical Center
Pittsburgh, PA United States
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Addison May, MD

Vanderbilt University Medical Center
Nashville, TN United States
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Joseph Minei, MD

UT Southwestern Medical Center
Dallas, TX United States
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Wayne M Dankner, MD

Texas Tech University Health Sciences Center at El Paso
El Paso, TX United States
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Therese Duane, MD

John Peter Smith Health Network
Fort Worth, TX United States
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Stephanie Gordy, MD

Baylor College of Medicine-Ben Taub Hospital
Houston, TX United States
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Daniel Bonville, MD

Houston Methodist Hospital
Houston, TX United States
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Deborah Muellar, MD

University of Texas Health Science Center at San Antonio
San Antonio, TX United States
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Wayne M Dankner, MD

Virginia Commonwealth University
Richmond, VA United States
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Eileen M Bulger, MD

Harborview Medical Center
Seattle, WA United States
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Todd Neideen, MD

Medical College of Wisconsin-Froedtert Hospital
Milwaukee, WI United States
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