A Study of CB-183,315 in Patients With Clostridium Difficile Associated Diarrhea
Study type: Interventional What is this?
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study phase: III What is this?
During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.
- Rochester, Minnesota: 13-000794
NCT ID: NCT01598311
Sponsor Protocol Number: LCD-CDAD-11-06
About this study
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.
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.
See eligibility criteria
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.
Participating Mayo Clinic locations
Study statuses change often. Please contact us for help.