Study of CB-183,315 in Patients With Clostridium Difficile Associated Diarrhea



Status:Completed
Conditions:Infectious Disease, Gastrointestinal
Therapuetic Areas:Gastroenterology, Immunology / Infectious Diseases
Healthy:No
Age Range:18 - 90
Updated:2/8/2015
Start Date:May 2012
End Date:May 2015
Contact:Mary E Sweeney
Email:mary.sweeney@incresearch.com
Phone:6102392764

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

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.


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.
We found this trial at
70
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Modesto, CA
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Akron, OH
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Bismark, ND
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Boston, MA
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Clearwater, FL
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Cleveland, OH
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Colton, CA
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Columbus, OH
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Dallas, TX
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421 East Canfield Street
Detriot, Michigan 48201
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Fargo, ND
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Mexico, MO
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Minneapolis, MN
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Sellersville, Pennsylvania 18960
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