study of cb-183,315 in participants with clostridium difficile associated diarrhea (mk-4261-005)

Conditions: Clostridium Difficile Infection

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.

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