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

• Status: Completed
• Trial end date: 2015-03-20
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cubist Pharmaceuticals LLC
• Treatments: Vancomycin

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.