Study of CB-183,315 in Participants With Clostridium Difficile Infection
Public ClinicalTrials.gov record NCT01085591. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Randomized, Double-Blinded, Active-Controlled, Dose Ranging Study of CB-183,315 in Patients With Clostridium Difficile Infection.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT01085591
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Lead sponsor
- Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
- Industry
- Enrollment
- 210 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Mar 31, 2010
- Primary completion
- Apr 12, 2011
- Completion
- May 12, 2011
- Last update posted
- Sep 10, 2018
2010 – 2011
United States locations
- U.S. sites
- 22
- U.S. states
- 17
- U.S. cities
- 20
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Providence Hospital Clinical Research Center | Washington D.C. | District of Columbia | — | — |
| Washington Hospital Center | Washington D.C. | District of Columbia | — | — |
| Central Florida Internists | Saint Cloud | Florida | — | — |
| Atlanta Institute for Medical Research, Inc | Decatur | Georgia | — | — |
| Gastrointestinal Specialists of Georgia PC | Marietta | Georgia | — | — |
| Wellstar Infectious Disease | Marietta | Georgia | — | — |
| Idaho Falls Infectious Disease, PLLC | Idaho City | Idaho | — | — |
| University of Chicago | Chicago | Illinois | — | — |
| University of Kansas Medical Center | Kansas City | Kansas | — | — |
| Ochsner Clinic Foundation | New Orleans | Louisiana | — | — |
| Metropolitan Gastroentrology Group | Chevy Chase | Maryland | — | — |
| Tufts University School of Medicine | Boston | Massachusetts | — | — |
| Henry Ford Health System | Detroit | Michigan | — | — |
| Not listed | Keego Harbor | Michigan | 48320 | — |
| William Beaumont Hospital | Royal Oak | Michigan | — | — |
| University of Minnesota | Minneapolis | Minnesota | — | — |
| Missouri Baptist Medical Center | St Louis | Missouri | — | — |
| Mercury Street Medical Group - Research Group | Butte | Montana | — | — |
| DiGiovanna Institute for Medical Education and Research | North Massapequa | New York | — | — |
| Wake Forest University Health Sciences | Winston-Salem | North Carolina | — | — |
| MeritCare Clinical Research | Fargo | North Dakota | — | — |
| Remington Davis Inc. | Columbus | Ohio | — | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 10 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01085591, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 10, 2018 · Synced Sep 8, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01085591 live on ClinicalTrials.gov.