Study of CB-183,315 in Participants With Clostridium Difficile Associated Diarrhea (MK-4261-005)
Condition: Clostridium Difficile Infection
MeSH terms: Clostridium Infections; Diarrhea
Intervention: Surotomycin; Vancomycin; Placebo
Intervention description: 250 mg Surotomycin over-encapsulated tablet administered orally, twice daily for a daily total dose of 500 mg, for 10 days; 125 mg Vancomycin over-encapsulated capsule administered orally, four times daily for a daily total dose of 500 mg, for 10 days; Placebo for Surotomycin over-encapsulated tablet administered orally, twice daily for 10 days
Intervention MeSH terms: Vancomycin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 606.0
Sex: All
Minimum age: 18 Years
Maximum age: 90 Years
Healthy volunteers: No
Keywords: CDAD; Clostridium difficile Associated Diarrhea; CDI; Clostridium difficile Infection; Diarrhea

Summary:

      606 participants with Clostridium Difficile Associated Diarrhea (CDAD) participated in this
      study and received either oral vancomycin or CB-183,315 (surotomycin) in a blinded fashion.
      Treatment lasted for 10 days and participants were followed up for at least 40 days and a
      maximum of 100 days. The purpose of this study was to evaluate how well surotomycin treats
      CDAD as compared to vancomycin.
    

Eligibility criteria:

        To be included in this study, participants must:

          -  Sign a consent form;

          -  Be >= 18 and < 90 years of age;

          -  Have diarrhea, at least 3 times during one day, or 200 mL or liquid stool if using a
             rectal device;

          -  Test positive for Clostridium difficile;

          -  If female, must not be pregnant or nursing and take appropriate measures to not get
             pregnant during the study.

        Participants will not be allowed into the study if they:

          -  Have toxic megacolon and/or known small bowel ileus;

          -  Have received treatment with intravenous immune globulin (IVIG) within the past 30
             days;

          -  Have received treatment with a fecal transplant within 7 days, and/or if the doctor
             anticipates to give the participant a fecal transplant during the study;

          -  Have received a certain amount of antibacterial therapy specific for current CDAD,
             unless it is not working;

          -  Have received an investigational vaccine against C. difficile;

          -  Have received an investigational product containing monoclonal antibodies against
             toxin A or B within 180 days;

          -  Had more than 2 episodes of CDAD within 90 days;

          -  Had major gastrointestinal (GI) surgery (i.e. significant bowel resection) within 3
             months (this does not include appendectomy or cholecystectomy);

          -  Have history of prior inflammatory bowel disease: ulcerative colitis, Crohn's disease,
             or microscopic colitis;

          -  Are unable to discontinue loperamide, diphenoxylate/atropine, or cholestyramine during
             the duration of the study;

          -  Are unable to discontinue opiate treatment unless on a stable dose;

          -  Has known positive stool cultures for other enteropathogens including but not limited
             to Salmonella, Shigella, and Campylobacter;

          -  Had stool studies positive for pathogenic ova and/or parasites;

          -  Have an intolerance or hypersensitivity to daptomycin and/or vancomycin;

          -  Have life-threatening illness at the time of enrollment;

          -  Have poor concurrent medical risks that in the opinion of the Investigator the
             participant should not enroll;

          -  Have received an investigational drug or participated in any experimental procedure
             within 1 month;

          -  Have human immunodeficiency virus (HIV), a cluster of differentiation 4 (CD4) < 200
             cells/mm3 within 6 months of start of study therapy;

          -  Anticipate that certain antibacterial therapy for a non-CDAD infection will be
             required for > 7 days;

          -  Are unable to discontinue Saccharomyces or similar probiotic;

          -  Are on a concurrent intensive induction chemotherapy, radiotherapy, or biologic
             treatment for active malignancy;

          -  Are unable to comply with the protocol requirements;

          -  Have any condition that, in the opinion of the Investigator, might interfere;

          -  Are not expected to live for less than 8 weeks.