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

Completed · Phase 2 · Has a placebo group

Conditions studied: Clostridium Infections

In brief

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.

Key facts

Study ID

NCT00350298

Run by

MassBiologics

People needed

200

Starts

2006-07-20

Expected to finish

2008-06-25

Last updated by the study team

2021-02-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patient > 18 years of age with diarrhea associated with a positive stool test for C. difficile toxin(s). Patients may be diagnosed with C. difficile by hospital/clinic/reference microbiology laboratory test or by a rapid diagnostic test performed by the study staff and positive test result must be within 14 days of enrollment.
• Patient must receive standard of care treatment for C. difficile associated disease. Standard of care treatment should include either metronidazole by mouth or intravenously or vancomycin by mouth.
• Patient or legal representative must have read, understood, and provided written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization after the nature of the study has been fully explained.

You may not qualify if…

• History of chronic diarrheal illness such as ulcerative colitis or Crohn's disease.
• Score of 4 on modified Horn's index
• Severe C. difficile colitis with planned surgery in less than 24 hours.
• Positive pregnancy test within 24 hours of study infusion or an unwillingness to undergo pregnancy testing in females of child-bearing potential. Females capable of child-bearing must agree not to become pregnant from the time of study enrollment until at least 3 months after completion of study infusion. If a woman is sexually active and has no history of hysterectomy or tubal ligation, she must agree to use hormonal or barrier birth control with spermicidal gel.
• Breastfeeding.
• Receipt of other investigational study agent within previous 30 days.
• Any other condition that in the opinion of the investigator would jeopardize the safety or rights of the patient participating in the study or make it unlikely the patient could complete the study.

Where it is running

• 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
• 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

Full record on ClinicalTrials.gov

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