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