A Study of CB-183,315 in Participants With Clostridium Difficile Associated Diarrhea (MK-4261-006)
A Study of CB-183,315 in Participants With Clostridium Difficile Associated Diarrhea (MK-4261-006)
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.
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.