a study of cb-183,315 in participants with clostridium difficile associated diarrhea (mk-4261-006)

Conditions: Clostridium Difficile Infection

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.

Keywords: cdad clostridium difficile associated diarrhea cdi clostridium difficile infection diarrhea