Study of CB-183,315 in Participants With Clostridium Difficile Infection
A Randomized, Double-Blinded, Active-Controlled, Dose Ranging Study of CB-183,315 in Patients With Clostridium Difficile Infection.
2 other identifiers
interventional
210
2 countries
32
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Apr 2010
Shorter than P25 for phase_2
32 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 9, 2010
CompletedFirst Posted
Study publicly available on registry
March 12, 2010
CompletedStudy Start
First participant enrolled
April 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 13, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
May 13, 2011
CompletedResults Posted
Study results publicly available
June 16, 2015
CompletedSeptember 11, 2018
August 1, 2018
1 year
March 9, 2010
April 21, 2015
August 13, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Number of Participants With a Clinical Response Outcome of Clostridium Difficile Infection Cure at the End of Study Treatment
The number of participants with an Investigator-assessed clinical response of cure is presented. The information to assess clinical response was collected at any time up to and including Day 19.
Baseline (Day 0) through Study Day 19
Number of Participants With a Clinical Response Outcome of Failure or Unable to Evaluate at the End of Study Treatment
The number of participants with investigator assessed clinical response of failure or unable to evaluate is presented. Clinical response was determined by the participant's condition on the second day following the last dose of study medication, unless considered a treatment failure. Treatment failures were assessed whenever they occurred and were carried forward to the end-of-treatment (EOT). The information to assess clinical response was collected at any time up to and including Day 19.
Baseline (Day 0) through Study Day 19
Secondary Outcomes (4)
Number of Participants With a Recurrence of Clostridium Difficile Infection Through the 4-week Follow-up Period
Study Day 10 up to Study Day 40
Number of Participants With a Clinical Response Outcome at the End of Study Treatment With and Without Infection Caused by C. Difficile BI/NAP1/027 Strain at Baseline
Baseline (Day 0) through Study Day 12
Number of Participants With a Recurrence of Clostridium Difficile Infection at the End of Study Treatment With and Without Infection Caused by C. Difficile BI/NAP1/027 Strain at Baseline
Study Day 10 up to Study Day 40
Median Time to Resolution of Diarrhea
Baseline (Day 0) through Study Day 12
Study Arms (3)
CB-183,315, 125 mg
EXPERIMENTAL125 milligrams (mg) CB 183,315 administered orally twice daily, alternating with twice daily oral administration of placebo tablets, for 10 days.
CB-183,315, 250 mg
EXPERIMENTAL250 mg CB 183,315 administered orally twice daily, alternating with twice daily oral administration of placebo tablets, for 10 days.
Vancomycin, 125 mg
ACTIVE COMPARATOR125 mg vancomycin administered orally four times a day for 10 days.
Interventions
Eligibility Criteria
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
- +23 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (32)
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
Unknown Facility
Keego Harbor, Michigan, 48320, 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
Mount Sinai Hospital
Toronto, Ontario, Canada
Centre de Sante et des Services Sociaux de Chicoutimi
Chicoutimi, Quebec, Canada
Maisonneuve Rosemont Hospital
Montreal, Quebec, Canada
SMBD- Jewish General Hospital G-139
Montreal, Quebec, Canada
Centre Hospitalier Universitaire de Québec
Québec, Quebec, Canada
Centre Hospitalier Universitaire de Sherbrooke
Sherbrook, Quebec, Canada
Centre hopitalier regional de Trois-Rivieres
Trois-Rivières, Quebec, Canada
Related Publications (1)
Lee CH, Patino H, Stevens C, Rege S, Chesnel L, Louie T, Mullane KM. Surotomycin versus vancomycin for Clostridium difficile infection: Phase 2, randomized, controlled, double-blind, non-inferiority, multicentre trial. J Antimicrob Chemother. 2016 Oct;71(10):2964-71. doi: 10.1093/jac/dkw246. Epub 2016 Jul 17.
PMID: 27432604RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Vice President, Clinical Research
- Organization
- Cubist Pharmaceuticals, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 9, 2010
First Posted
March 12, 2010
Study Start
April 1, 2010
Primary Completion
April 13, 2011
Study Completion
May 13, 2011
Last Updated
September 11, 2018
Results First Posted
June 16, 2015
Record last verified: 2018-08
Data Sharing
- IPD Sharing
- Will share
https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf