Study of the Clinical Effectiveness of a Human Monoclonal Antibody to C. Difficile Toxin A and Toxin B in Patients With Clostridium Difficile Associated Disease

PHASE2CompletedINTERVENTIONAL
Enrollment

200

Participants

Timeline

Start Date

July 20, 2006

Primary Completion Date

June 25, 2008

Study Completion Date

June 25, 2008

Conditions
Clostridium Infections
Interventions
BIOLOGICAL

GS-CDA1/MDX-1388

One Intravenous dose

BIOLOGICAL

normal saline

One Intravenous dose

Trial Locations (29)

10029

Mount Sinai Hospital, New York

19718

Christiana Care Health Systems, Newark

27103

All-Trials Clinical Research, LLC, Winston-Salem

33613

Dr. Kiran C. Patel Research Institute, Tampa

40536

University of Kentucky Medical Center, Lexington

43214

Remington-Davis Clinical Research, Columbus

44304

Summa Health System, Akron

46016

Central Indiana Gastroenterology Group, Anderson

48322

Henry Ford Health System, West Bloomfield

50325

Chest, Infectious Diseases and Critical Care Assoc., PC, Des Moines

55905

Mayo Clinic, Rochester

57701

Rapid City Regional Hospital, Rapid City

59701

Saint James Healthcare, Butte

64111

Saint Luke's Hospital of Kansas City, Kansas City

76508

Scott and White Memorial Hospital, Temple

77030

St. Lukes Episcopal Hospital, Houston

83404

Idaho Falls Infectious Diseases, PLLC, Idaho Falls

90033

LAC/USC Medical Center, Los Angeles

90095

UCLA CURE Digestive Diseases Center, Los Angeles

94612

Kaiser Permanente Vaccine Study Center, Oakland

98405

MultiCare Health System Research Services, Tacoma

07754

Jersey Shore University Medical Center, Neptune City

T2N 2T9

University of Calgary Foothills Medical Center, Calgary

V8R 1J8

Vancouver Island Health Research Centre, Victoria

R3A 1R9

Health Sciences Centre, University of Manitoba, Winnepeg

K7L 2V7

Kingston General Hospital, Kingston

N8W 1L9

Windsor Regional Hospital, Windsor

G7H 5H6

Centre de Sante et Services Sociaux de Chicoutimi, Chicoutimi

G8Z 3R9

Centre Hospitalier Regional de Trois-Rivieres, Trois-Rivières

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

Medarex

INDUSTRY

lead

MassBiologics

OTHER