A Study of CB-183,315 in Participants With Clostridium Difficile Associated Diarrhea (MK-4261-006)
Condition: Clostridium Difficile Infection
MeSH terms: Clostridium Infections; Diarrhea
Intervention: CB-183,315; Vancomycin; Placebo
Intervention description: CB-183,315 250 mg white coated tablet over-encapsulated in a size 00 opaque hard gelatin capsule.; Vancomycin hydrochloride 125 mg capsule over-encapsulated in size 00 opaque hard gelatin capsule.; Placebo size 00 opaque hard gelatin capsules.
Intervention MeSH terms: Vancomycin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 608.0
Sex: All
Minimum age: 18 Years
Maximum age: 89 Years
Healthy volunteers: No
Keywords: CDAD; Clostridium difficile Associated Diarrhea; CDI; Clostridium difficile Infection; Diarrhea

Summary:

      A total of 608 participants with Clostridium Difficile Associated Diarrhea (CDAD) will
      participate in this study; participants will receive either oral vancomycin or CB-183,315 in
      a blinded fashion. Treatment will last for 10 days and participants will be followed up for
      at least 40 days and a maximum of 100 days. The purpose of this study is to evaluate how well
      CB-183,315 treats CDAD as compared to vancomycin.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Is able to read and sign a consent form;

          -  Is from ≥18 to <90 years of age;

          -  Has diarrhea, at least 3 times during one day, or 200 mL or liquid stool if using a
             rectal device;

          -  Tests positive for Clostridium difficile;

          -  If female, must not be pregnant or nursing and take appropriate measures to not get
             pregnant during the study.

        Exclusion Criteria:

          -  Has toxic megacolon and/or known small bowel ileus;

          -  Has received treatment with intravenous immune globulin (IVIG) within the past 30
             days;

          -  Has 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;

          -  Has received a certain amount of antibacterial therapy specific for current CDAD,
             unless it is not working;

          -  Has received an investigational vaccine against Clostridium difficile;

          -  Has received an investigational product containing monoclonal antibodies against toxin
             A or B within 180 days;

          -  Has more than 2 episodes of CDAD within 90 days;

          -  Has had major gastrointestinal (GI) surgery (i.e. significant bowel resection) within
             3 months (this does not include appendectomy or cholecystectomy);

          -  Has a history of prior inflammatory bowel disease: ulcerative colitis, Crohn's
             disease, or microscopic colitis;

          -  Is unable to discontinue loperamide, diphenoxylate/atropine, or cholestyramine during
             the duration of the study;

          -  Is 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;

          -  Has had stool studies positive for pathogenic ova and/or parasites;

          -  Has an intolerance or hypersensitivity to daptomycin and/or vancomycin;

          -  Has a life-threatening illness at the time of enrollment;

          -  Has poor concurrent medical risks that in the opinion of the Investigator the
             participant should not enroll;

          -  Has received an investigational drug or participated in any experimental procedure
             within 1 month;

          -  Has human immunodeficiency virus (HIV), a cluster of differentiation (CD) 4 count <200
             cells/mm^3 within 6 months of start of study therapy;

          -  Anticipates that certain antibacterial therapy for a non-CDAD infection will be
             required for >7 days;

          -  Is unable to discontinue Saccharomyces or similar probiotic;

          -  Is on a concurrent intensive induction chemotherapy, radiotherapy, or biologic
             treatment for active malignancy;

          -  Is unable to comply with the protocol requirements;

          -  Has any condition that, in the opinion of the Investigator, might interfere;

          -  Is not expected to live for less than 8 weeks.