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
Condition: Clostridium Infections
MeSH terms: Clostridium Infections
Intervention: GS-CDA1/MDX-1388; normal saline
Intervention description: One Intravenous dose; One Intravenous dose
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 200.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Monoclonal antibody,; Clostridium difficile Associated Diarrhea

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.
    

Eligibility criteria:

        Inclusion Criteria:

          1. 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.

          2. 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.

          3. 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 Criteria:

          1. History of chronic diarrheal illness such as ulcerative colitis or Crohn's disease.

          2. Score of 4 on modified Horn's index

          3. Severe C. difficile colitis with planned surgery in less than 24 hours.

          4. 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.

          5. Breastfeeding.

          6. Receipt of other investigational study agent within previous 30 days.

          7. 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.