Phase 3
N=608
A Study of CB-183,315 in Participants With Clostridium Difficile Associated Diarrhea (MK-4261-006)
Clostridium Difficile Infection
Bottom Line
View on ClinicalTrials.gov: NCT01598311 ↗Enrolled (actual)
608
Serious AEs
12.1%
Results posted
Feb 2018
Primary outcome: Primary: Adjusted Percentage of Participants Meeting Clinical Response Criteria for Cure at End of Treatment (EOT) — 83.4; 82.1 Adjusted percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- CB-183,315 (Drug); Vancomycin (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
- Primary completion
- Jul 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Adjusted Percentage of Participants Meeting Clinical Response Criteria for Cure at End of Treatment (EOT) |
83.4; 82.1 | — |
| PRIMARY Percentage of Participants Experiencing an Adverse Event (AE) |
52.4; 60.1 | — |
| PRIMARY Percentage of Participants Discontinuing From Study Treatment Due to an AE |
3.7; 3.0 | — |
| SECONDARY Number of Clinical Failure Events up to Day 40 |
48; 54; 42; 49; 11; 11 | — |
| SECONDARY Adjusted Percentage of Participants With Sustained Clinical Response at End of Study |
63.3; 59.0 | — |
Summary
A total of 608 participants with Clostridium Difficile Associated Diarrhea (CDAD) will participate in this study; participants will 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.
Eligibility Criteria
Inclusion Criteria
- Is able to read and sign a consent form;
- Is from ≥18 to 7 days;
- Is unable to discontinue Saccharomyces or similar probiotic;
- Is on a concurrent intensive induction chemotherapy, radiotherapy, or biologic treatment for active malignancy;
- Is unable to comply with the protocol requirements;
- Has any condition that, in the opinion of the Investigator, might interfere;
- Is not expected to live for less than 8 weeks.
Data sourced from ClinicalTrials.gov (NCT01598311). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.