Study of CB-183,315 in Participants With Clostridium Difficile Infection

Completed · Phase 2 · Has a placebo group

Conditions studied: Clostridium Difficile Infection, Diarrhea

In brief

This is a randomized, double-blind, single-placebo, active-controlled, dose ranging parallel group design with 3 arms. Two dose regimens of CB-183,315 dosed twice daily will be compared with the active comparator oral vancomycin (125 milligrams (mg ) four times daily). Participants with diarrhea at risk for Clostridium difficile infection (CDI) \[for example, received prior or concomitant antibiotic(s)\] will be identified and tested for C. difficile toxin in stool using an enzyme immunoassay (EIA), or polymerase chain reaction (PCR) per the usual standard of care. Eligible participants will be consented, undergo baseline evaluations, and will be randomized in a blinded fashion to one of 3 treatment arms. Participants will be randomized to receive either 125 mg CB-183,315 twice daily alternating with placebo tablets twice daily, 250 mg CB-183,315 twice daily alternating with placebo tablets twice daily or 125 mg oral vancomycin four times dailyover a period of 10 days in a 1:1:1 fashion.

Key facts

Study ID

NCT01085591

Run by

Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

People needed

210

Starts

2010-04-01

Expected to finish

2011-05-13

Last updated by the study team

2018-09-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• A participant will not be enrolled if s/he meets any of the following criteria:
• Female and pregnant or lactating
• Toxic megacolon and/or known small bowel ileus
• Received treatment with intravenous (IV) immune globulin within 30 days prior to the first dose of study drug
• Antibacterial therapy specific for current CDI or that may be effective for CDI even if given for a different indication:
• Received more than 24 hours of oral vancomycin for the current episode of CDI prior to first dose of study drug.
• Received more than 24 hours of oral/intravenous metronidazole OR any other therapy specific for the current episode of CDI immediately prior to first dose of study drug unless the participant received at least 3 days of such therapy, and is considered a treatment failure for CDI.
• Received more than 24 hours of oral/intravenous metronidazole for any other indication in the 3 days prior to first dose of study drug.
• Participants with more than 2 episodes of CDI within 90 days (that is, participants can be enrolled with their 1st recurrence/2nd episode)
• Major gastrointestinal (GI) surgery (that is, significant bowel resection including total colectomy with ileostomy) within 3 months of enrollment (this does not include appendectomy or cholecystectomy)
• History of prior inflammatory bowel disease: ulcerative colitis, Crohn's disease, or microscopic colitis
• Unable to stop loperamide, diphenoxylate, and cholestyramine during the duration of the study
• Unable to stop opiate treatment, unless on a stable dose as of onset of diarrhea and no change in dose planned for the duration of the study
• Known positive stool cultures for other enteropathogens, including but not limited to Salmonella, Shigella and Campylobacter
• Known stool studies positive for ova and/or parasites
• Known intolerance or hypersensitivity to daptomycin and/or vancomycin
• Poor concurrent medical risks with clinically significant co-morbid disease such that in the opinion of the Investigator the participant should not be enrolled
• Received an investigational drug or participated in any experimental procedure within 1 month prior to study entry
• Previously enrolled in this study
• Received an investigational vaccine against C. difficile
• Participants with known Hepatitis B or Hepatitis C who have alanine aminotransferase or aspartate aminotransferase > 2.5 times the upper limit of normal (ULN) and/or bilirubin > 1.5 times the ULN
• Human immunodeficiency virus positive, unless controlled (that is, on triple therapy) and with a CD4 > 200 cells per millimeter cubed (cellsmm˄3)
• Anticipated that systemic antibacterial therapy for a non-CDI infections will be required for >7 days after start of study therapy
• Concurrent therapy with daptomycin
• Unable to discontinue Saccharomyces or similar probiotic

Where it is running

• Providence Hospital Clinical Research Center — Washington D.C., District of Columbia, United States
• Washington Hospital Center — Washington D.C., District of Columbia, United States
• Central Florida Internists — Saint Cloud, Florida, United States
• Atlanta Institute for Medical Research, Inc — Decatur, Georgia, United States
• Gastrointestinal Specialists of Georgia PC — Marietta, Georgia, United States
• Wellstar Infectious Disease — Marietta, Georgia, United States
• Idaho Falls Infectious Disease, PLLC — Idaho City, Idaho, United States
• University of Chicago — Chicago, Illinois, United States
• University of Kansas Medical Center — Kansas City, Kansas, United States
• Ochsner Clinic Foundation — New Orleans, Louisiana, United States
• Metropolitan Gastroentrology Group — Chevy Chase, Maryland, United States
• Tufts University School of Medicine — Boston, Massachusetts, United States
• Henry Ford Health System — Detroit, Michigan, United States
• Study site — Keego Harbor, Michigan, United States
• William Beaumont Hospital — Royal Oak, Michigan, United States
• University of Minnesota — Minneapolis, Minnesota, United States
• Missouri Baptist Medical Center — St Louis, Missouri, United States
• Mercury Street Medical Group - Research Group — Butte, Montana, United States
• DiGiovanna Institute for Medical Education and Research — North Massapequa, New York, United States
• Wake Forest University Health Sciences — Winston-Salem, North Carolina, United States
• MeritCare Clinical Research — Fargo, North Dakota, United States
• Remington Davis Inc. — Columbus, Ohio, United States
• University of Calgary, Foothills Medical Center — Calgary, Alberta, Canada
• St. Joseph Healthcare — Hamilton, Ontario, Canada
• Queen's University — Kingston, Ontario, Canada

Full record on ClinicalTrials.gov

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