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

Summary

Patients with Clostridium difficile associated disease who fulfill the eligibility criteria will be approached to participate. All study patients must receive standard of care treatment for Clostridium difficile associated disease. Enrolled patients will be randomized to receive a single intravenous solution of a human monoclonal antibody (huMab) to C. difficile toxin A (GS-CDA1) combined with a human monoclonal antibody to C. difficile toxin B (MDX-1388) or 0.9% sodium chloride as placebo in a 1:1 treatment allocation. Patients will be evaluated for safety and clinical outcomes through day 84 +/- 10 days. Occurrence of adverse events, use of concomitant medications, and stool output will be assessed at scheduled phone contacts and study visits. Some patients enrolled will have a subsequent visit on day 168 ± 14 days.

Conditions

• Clostridium Infections

Interventions

BIOLOGICAL

GS-CDA1/MDX-1388

One Intravenous dose

BIOLOGICAL

normal saline

One Intravenous dose

Sponsors & Collaborators

• Medarex

  collaborator INDUSTRY

• MassBiologics

  lead OTHER

Principal Investigators

• Roger Baxter, MD · Kaiser Permanente

• Herbert DuPont, MD · St. Lukes Episcopal Hospital, Houston, TX

• Joseph White, MD · Scott and White Memorial Hospital, Temple, TX

• David Chen, MD · MultiCare Health System Research Services, Tacoma, WA

• Jorge Reyno, MD · Rapid City Regional Hospital, Rapid City, SD

• Henry S. Sacks, MD, PhD · Mount Sinai Hospital, New York, NY

• Charles N. Bernstein, MD · University of Manitoba, Health Sciences Centre, Winnepeg, Manitoba, Canada

• Michael J. Tan, MD · Summa Health Systems, Akron, Ohio

• Michael C. Meadors, MD · All-Trials Clinical Research, LLC, Winston-Salem, NC

• Ian M. Baird, MD · Remington-Davis Clinical Research

• Andre Poirier, MD, MSc · Centre Hospitalier Regional de Trois-Rivieres

• Martha I. Buitrago, MD · Idaho Falls Infectious Diseases, PLLC

• Thomas Kovacs, MD · UCLA CURE Digestive Diseases Research Center

• Alfred Bacon, MD · Christiana Care Health Systems

• Kathleen Casey, MD · Jersey Shore University Medical Center

• C. Douglas Cochran, MD · St. Luke's Hospital, Kansas City, Missouri

• Donald Daly, MD · Vancouver Island Health Research Centre

• Anil Dhar, MBBS · Windsor Regional Hospital

• Gerald Evans, MD · Kingston Health Sciences Centre

• Richard Greenberg, MD · University of Kentucky

• Thomas Louie, MD · University of Calgary Foothills Medical Center

• Thomas Nowak, MD · Central Indiana Gastroenterology Group

• Jose Prieto, MD · Dr. Kiran C. Patel Research Institute

• Daniel Schroeder, MD · Chest, Infectious Diseases and Critical Care Assoc., PC

• Ann Silverman, MD · Henry Ford Health System

• John Pullman, MD · Mercury Street Medical Group

• Rodney J Mason, MD · LAC+USC Medical Center

• Doria Grimard, MD · Centre de Sante et de Services Sociaux de Chicoutimi

• Darrell Pardi, MD · Mayo Clinic

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2006-07-20

Primary Completion

2008-06-25

Completion

2008-06-25

Countries

• United States
• Canada

Study Locations