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Clinical trialNCT00350298CompletedPhase 2Interventional

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

SponsorMassBiologicsEnrollment200Clostridium Infections
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

29 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

Canada
  • University of Calgary Foothills Medical Center

    Calgary, Alberta, Canada

  • Vancouver Island Health Research Centre

    Victoria, British Columbia, Canada

  • Health Sciences Centre, University of Manitoba

    Winnepeg, Manitoba, Canada

  • Kingston General Hospital

    Kingston, Ontario, Canada

  • Windsor Regional Hospital

    Windsor, Ontario, Canada

  • Centre de Sante Et Services Sociaux de Chicoutimi

    Chicoutimi, Quebec, Canada

  • Centre Hospitalier Regional de Trois-Rivieres

    Trois-Rivières, Quebec, Canada

United States
  • Lac/usc Medical Center

    Los Angeles, California, United States

  • Ucla Cure Digestive Diseases Center

    Los Angeles, California, United States

  • Kaiser Permanente Vaccine Study Center

    Oakland, California, United States

  • Christiana Care Health Systems

    Newark, Delaware, United States

  • Dr. Kiran C. Patel Research Institute

    Tampa, Florida, United States

  • Idaho Falls Infectious Diseases, Pllc

    Idaho Falls, Idaho, United States

  • Central Indiana Gastroenterology Group

    Anderson, Indiana, United States

  • Chest, Infectious Diseases and Critical Care Assoc., Pc

    Des Moines, Iowa, United States

  • University of Kentucky Medical Center

    Lexington, Kentucky, United States

  • Henry Ford Health System

    West Bloomfield, Michigan, United States

  • Mayo Clinic

    Rochester, Minnesota, United States

  • Saint Luke'S Hospital of Kansas City

    Kansas City, Missouri, United States

  • Saint James Healthcare

    Butte, Montana, United States

  • Jersey Shore University Medical Center

    Neptune City, New Jersey, United States

  • Mount Sinai Hospital

    New York, New York, United States

  • All-Trials Clinical Research, Llc

    Winston-Salem, North Carolina, United States

  • Summa Health System

    Akron, Ohio, United States

  • Remington-Davis Clinical Research

    Columbus, Ohio, United States

  • Rapid City Regional Hospital

    Rapid City, South Dakota, United States

  • St. Lukes Episcopal Hospital

    Houston, Texas, United States

  • Scott and White Memorial Hospital

    Temple, Texas, United States

  • Multicare Health System Research Services

    Tacoma, Washington, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

GS-CDA1/MDX-1388Normal saline
Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
20 Jul 2006
Primary completion
25 Jun 2008
Completion
25 Jun 2008
Last update posted
9 Feb 2021
Registered enrollment
200
Registry id
NCT00350298

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.