Study of CB-183,315 in Participants With Clostridium Difficile Associated Diarrhea (MK-4261-005)
Study of CB-183,315 in Participants With Clostridium Difficile Associated Diarrhea (MK-4261-005)
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.
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.