Status:
COMPLETED
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
Lead Sponsor:
MassBiologics
Collaborating Sponsors:
Medarex
Conditions:
Clostridium Infections
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 Clostridiu...
Detailed Description
This study is a phase II, randomized, double-blind, placebo-controlled study in patients diagnosed with Clostridium difficile associated disease. Patients with Clostridium difficile associated disease...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
July 20 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 25 2008
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT00350298
Start Date
July 20 2006
End Date
June 25 2008
Last Update
February 9 2021
Active Locations (29)
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1
LAC/USC Medical Center
Los Angeles, California, United States, 90033
2
UCLA CURE Digestive Diseases Center
Los Angeles, California, United States, 90095
3
Kaiser Permanente Vaccine Study Center
Oakland, California, United States, 94612
4
Christiana Care Health Systems
Newark, Delaware, United States, 19718