A Randomized, Double-Blinded, Active-Controlled Study of CB-183,315 in Patients With Clostridium Difficile Associated Diarrhea

Location:

Rochester, Minn.

Trial status:

Open for Enrollment

Why is this study being done?

608 patients with Clostridium Difficile Associated Diarrhea (CDAD) will participate in this study and 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.

Who is eligible to participate?

To be included in this study, participants must: - Sign a consent form; - Be older 18 or older and 90 or younger; - 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 HIV, a 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.

Last updated:

10/9/2014

NCT ID:

NCT01598311

IRB Number:

13-000794