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

PHASE3CompletedINTERVENTIONAL
Enrollment

290

Participants

Timeline

Start Date

December 1, 2015

Primary Completion Date

August 18, 2019

Study Completion Date

October 18, 2019

Conditions
Necrotizing Soft Tissue InfectionsNecrotizing FasciitisFournier's Gangrene
Interventions
DRUG

AB103 0.5 mg/kg

OTHER

NaCl 0.9%

Trial Locations (71)

10305

Staten Island University Hospital-Northwell Health, Staten Island

12208

Albany Medical Center, Albany

14215

Erie County Medical Center-Affliate of SUNYat Buffalo, Buffalo

15213

University of Pittsburgh Medical Center, Pittsburgh

17033

The Pennsylvania State University and The Milton S. Hershey Medical Center, Hershey

18015

St. Luke's University Health Network, Bethlehem

19104

The Trauma Center at PENN, Philadelphia

19107

Thomas Jefferson University, Philadelphia

20010

Washington Hospital Center, Washington D.C.

21201

University of Maryland R Adams Cowley Shock Trauma Center, Baltimore

24857

Banner University Medical Center, Tucson

27834

East Carolina University, Greenville

28208

Carolinas Medical Center, Charlotte

30303

Emory University at Grady Memorial Hospital, Atlanta

30912

Augusta University Health, Augusta

32610

UF Health Shands Hospital, Gainesville

33136

Ryder Trauma Center/Jackson Memorial Hospital, Miami

35294

University of Alabama at Birmingham, Birmingham

37232

Vanderbilt University Medical Center, Nashville

40536

University of Kentucky, Lexington

43210

The Ohio State University, Columbus

44109

The MetroHealth System, Cleveland

44501

St Elizabeth Youngstown Hospital, Youngstown

45219

University of Cincinnati Medical Center (UCMC), Cincinnati

45409

Wright State University & Premier Health Clinical Trials Research Alliance, Dayton

48109

University of Michigan, Ann Arbor

48201

Wayne State University-Detroit Receiving Hospital, Detroit

48202

Henry Ford Health System, Detroit

48235

Wayne State University-Sinai Grace Hospital, Detroit

52242

University of Iowa Hospital and Clinics, Iowa City

53226

Medical College of Wisconsin-Froedtert Hospital, Milwaukee

55415

Hennepin County Medical Center, Minneapolis

55435

Fairview Southdale Hospital, Edina

55455

University of Minnesota Medical Center-Fairview, Minneapolis

63103

St Louis University, St Louis

65211

University of Missouri, Columbia

70112

LSU Health Science Center, New Orleans

70808

Our Lady of the Lake Regional Medical Center, Baton Rouge

70809

Baton Rouge General Hospital, Baton Rouge

72205

University of Arkansas for Medical Sciences, Little Rock

76104

John Peter Smith Health Network, Fort Worth

76502

Scott and White Medical Center, Temple

77030

Baylor College of Medicine-Ben Taub Hospital, Houston

78229

University of Texas Health Science Center at San Antonio, San Antonio

79905

Texas Tech University Health Sciences Center at El Paso, El Paso

80045

University of Colorado Hospital, Denver

80909

UCH-Memorial Health System, Colorado Springs

85008

Maricopa Medical Center, Phoenix

90502

Los Angeles Biomedical Research Institute at Harbor UCLA Medical Center, Los Angeles

92103

UCSD Medical Center, San Diego

92354

Loma Linda University Medical Center, Loma Linda

95817

University of California, Davis Medical Center, Sacramento

97227

Legacy Emanuel Hospital, Portland

97239

Oregon Health and Science University, Portland

98104

Harborview Medical Center, Seattle

98638

Capital Health System, Inc., Trenton

06520

Yale New Haven Hospital, New Haven

04102

Maine Medical Center, Portland

02114

Massachusetts General Hospital, Boston

02115

Brigham and Women's Hospital, Boston

08103

Cooper University Hospital, Camden

Unknown

Hộpital Estaing-CHU de Clermont-Ferrand, Clermont-Ferrand

Hộpital Henri Mondor, Créteil

Hôpital Bicêtre, Le Kremlin-Bicêtre

Robert Salengro Hopital-CHRU Lille, Lille

CHU de Limoges, Limoges

Hôpital Edouard Herriot, Lyon

CHRU Nancy, Hôpital Central, Nancy

CHU de Nimes, Nîmes

Hôpital de la Source, CHR Orleans, Orléans

CHRU Bretonneau, Tours

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Biomedical Advanced Research and Development Authority

FED

lead

Atox Bio Ltd

INDUSTRY

NCT02469857 - Phase III Efficacy and Safety Study of AB103 in the Treatment of Patients With Necrotizing Soft Tissue Infections | Biotech Hunter | Biotech Hunter