Phase 3
Completed N=606
Study of CB-183,315 in Participants With Clostridium Difficile Associated Diarrhea (MK-4261-005)
Clostridium Difficile Infection
Source: ClinicalTrials.gov NCT01597505 ↗
Enrolled (actual)
606
Serious AEs
13.7%
Results posted
Feb 2018
Primary outcomePrimary: Adjusted Percentage of Participants With a Clinical Outcome of Cure at the End of Treatment (EOT) — 79.0; 83.6 Percentage of participants
◆ Published Evidence
Established
72citations · ~8 / year
Primary Outcomes From a Phase 3, Randomized, Double-Blind, Active-Controlled Trial of Surotomycin in Subjects With <i>Clostridium difficile</i> Infection.
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.
Linked Publications (2)
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Primary Outcomes From a Phase 3, Randomized, Double-Blind, Active-Controlled Trial of Surotomycin in Subjects With <i>Clostridium difficile</i> Infection.
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Characterization of Clostridioides difficile isolates recovered from two Phase 3 surotomycin treatment trials by restriction endonuclease analysis, PCR ribotyping and antimicrobial susceptibilities.
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 | — |
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) and the linked publication. 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. Informational only — not medical advice.