Phase 3
N=606
Study of CB-183,315 in Participants With Clostridium Difficile Associated Diarrhea (MK-4261-005)
Clostridium Difficile Infection
Bottom Line
View on ClinicalTrials.gov: NCT01597505 ↗Enrolled (actual)
606
Serious AEs
13.7%
Results posted
Feb 2018
Primary outcome: Primary: Adjusted Percentage of Participants With a Clinical Outcome of Cure at the End of Treatment (EOT) — 79.0; 83.6 Percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Surotomycin (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
- Mar 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Adjusted Percentage of Participants With a Clinical Outcome of Cure at the End of Treatment (EOT) |
79.0; 83.6 | — |
| PRIMARY Percentage of Participants With at Least One Adverse Event (AE) |
48.5; 55.2 | — |
| PRIMARY Percentage of Participants With at Least One Serious Adverse Event (SAE) |
14.4; 12.9 | — |
| PRIMARY Percentage of Participants Who Discontinued Treatment Due to an AE |
5.6; 2.8 | — |
| SECONDARY Number of Participants With Clinical Response Over Time |
227; 231; 147; 151 | 0.832 |
| SECONDARY Adjusted Percentage of Participants With Sustained Clinical Response at the End of Study |
60.6; 61.4 | — |
| SECONDARY Adjusted Percentage of Participants With Sustained Clinical Response at Day 24 |
66.6; 66.1 | — |
| SECONDARY Adjusted Percentage of Participants With Recurrence of CDAD at End of Study |
17.7; 21.2 | — |
| SECONDARY Time to Resolution of Diarrhea |
2.8; 3.0 | 0.431 |
| SECONDARY Time to Reappearance of Diarrhea From End of Treatment to the End of Study |
NA; NA | 0.011 sig |
| SECONDARY Adjusted Percentage of Participants With a Clinical Response at the End of Treatment for Infections Deemed to be Caused by the C. Difficile BI/NAP1/027 Strain at Baseline |
88.5; 86.3 | — |
| SECONDARY Adjusted Percentage of Participants Per Protocol 1 Population With a Clinical Response at the End of Treatment |
89.1; 91.5 | — |
| SECONDARY Adjusted Percentage of Participants With a Sustained Clinical Response at the End of Study for Infections Deemed to be Caused by the C. Difficile BI/NAP1/027 Strain at Baseline |
66.1; 51.5 | — |
| SECONDARY Adjusted Percentage of Participants From the Per Protocol 2 Population With a Sustained Clinical Response at the End of Study |
70.8; 66.5 | — |
Summary
606 participants with Clostridium Difficile Associated Diarrhea (CDAD) participated in this study and received either oral vancomycin or CB-183,315 (surotomycin) in a blinded fashion. Treatment lasted for 10 days and participants were followed up for at least 40 days and a maximum of 100 days. The purpose of this study was to evaluate how well surotomycin treats CDAD as compared to vancomycin.
Eligibility Criteria
To be included in this study, participants must:
- Sign a consent form;
- Be >= 18 and 7 days;
- Are unable to discontinue Saccharomyces or similar probiotic;
- Are on a concurrent intensive induction chemotherapy, radiotherapy, or biologic treatment for active malignancy;
- Are unable to comply with the protocol requirements;
- Have any condition that, in the opinion of the Investigator, might interfere;
- Are not expected to live for less than 8 weeks.
Data sourced from ClinicalTrials.gov (NCT01597505). 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.