Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
Study of CB-183,315 in Participants With Clostridium Difficile Infection
NCT01085591 · View on ClinicalTrials.gov ↗
Study 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.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Vancomycin
- DRUG CB-183,315
Study Locations (20)
Georgia
- Atlanta Institute for Medical Research, Inc — Decatur
- Gastrointestinal Specialists of Georgia PC — Marietta
- Wellstar Infectious Disease — Marietta
Michigan
- Henry Ford Health System — Detroit
- — Keego Harbor
- William Beaumont Hospital — Royal Oak
District of Columbia
- Providence Hospital Clinical Research Center — Washington D.C.
- Washington Hospital Center — Washington D.C.
Florida
- Central Florida Internists — Saint Cloud
Idaho
- Idaho Falls Infectious Disease, PLLC — Idaho City
Illinois
- University of Chicago — Chicago
Kansas
- University of Kansas Medical Center — Kansas City
Louisiana
- Ochsner Clinic Foundation — New Orleans
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 210 participants |
| Start Date | 2010-04-01 |
| Est. Completion | 2011-05-13 |
| Phase | Phase 2 |
Sponsor
Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)11 total trials
Interested in This Trial?
Always speak with your doctor before enrolling in a clinical trial.
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01085591
The ClinicalTrials.gov registry entry for NCT01085591 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 210 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA), which has 11 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Diarrhea appearing as the primary indexed condition, and to 3 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT01085591 reports 20 study locations spanning 15 distinct geographic areas — top geographies include Georgia, Michigan, District of Columbia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT01085591 about?
NCT01085591 is a clinical study titled "Study of CB-183,315 in Participants With Clostridium Difficile Infection". 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 ...
What is the current status of trial NCT01085591?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 210 participants. The study started on 2010-04-01. Estimated completion is 2011-05-13.
What conditions does trial NCT01085591 study?
This clinical trial studies the following conditions: Diarrhea, Clostridium Difficile Infection. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT01085591?
The interventions under investigation include: Placebo (DRUG), Vancomycin (DRUG), CB-183,315 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT01085591?
This trial is sponsored by Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA), which has 11 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT01085591 being conducted?
This trial has 20 study locations across District of Columbia, Florida, Georgia, Idaho, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How Clinical Trials Work
Understand phases 1-4, trial design, randomization, and the informed consent process.
Patient Rights in Clinical Trials
Your rights as a participant: consent, withdrawal, privacy, and who to contact.
Finding the Right Clinical Trial
A practical guide to searching trials, understanding eligibility, and evaluating options.
All Guides
Browse our complete library of clinical trial educational resources.
Read our methodology — how this data is sourced, computed, and verified.