Adults 18 to 89, any sex, with Clostridium Difficile Infection. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Adjusted Percentage of Participants Meeting Clinical Response Criteria for Cure at End of Treatment (EOT)Primary· Up to 3 days after EOT (up to Day 13)
The percentage of participants considered "cured" (i.e., ≤2 loose stools per 24 hour period for at least 2 consecutive days and no need for additional antibiotics during the 3 days following EOT) was determined in the mMITT population. A CDAD diagnosis was defined as: 1) diarrhea with a minimum of 3 unformed bowel movements (UBM) or \>200 mL volume of stool for participants with a collection device (e.g., rectal tube or colostomy bag) over 24 hours; and 2) a positive result for Clostridium difficile toxin by enzyme immunoassay (EIA), polymerase chain reaction (PCR), or a cell culture cytotoxin
Group
Value
95% CI
CB-183,315
83.4
78.7 – 87.2
Vancomycin
82.1
77.2 – 85.9
Number of Clinical Failure Events up to Day 40Secondary· Up to 30 days after EOT (up to Day 40)
The total number of clinical failure events, which included treatment failure, CDAD recurrence, death, or being lost to follow-up, occurring during each time period was determined in each arm.
Day 0 to Day 13
Group
Value
95% CI
CB-183,315
48
Vancomycin
54
Day 14 to Day 24
Group
Value
95% CI
CB-183,315
42
Vancomycin
49
Day 25 to Day 35
Group
Value
95% CI
CB-183,315
11
Vancomycin
11
Day 36 to Day 40
Group
Value
95% CI
CB-183,315
2
Vancomycin
2
Adjusted Percentage of Participants With Sustained Clinical Response at End of StudySecondary· Up to 40 days after EOT (up to Day 50)
The percentage of participants with sustained clinical response was determined for each arm. Sustained clinical response was declared when participants had a clinical outcome of cure at EOT, did not experience any CDAD recurrence, did not die, were not lost to follow-up, and did not have the end of study visit prior to Day 40. Percentages were first stratified according to age (\<75 or ≥75 years) and number of previous CDAD episodes (0 or ≥1) and constructed using Mehrotra-Railkar continuity-corrected minimum-risk stratum weights, and the weighted averages were then derived across strata in or
Group
Value
95% CI
CB-183,315
63.3
57.7 – 68.7
Vancomycin
59.0
53.4 – 64.5
Percentage of Participants Experiencing an Adverse Event (AE)Primary· Up to 30 days after EOT (up to Day 40)
An AE is any untoward medical occurrence in a participant administered a pharmaceutical product that does not necessarily have to have a causal relationship with this treatment.
Group
Value
95% CI
CB-183,315
52.4
Vancomycin
60.1
Percentage of Participants Discontinuing From Study Treatment Due to an AEPrimary· Up to EOT (up to Day 10)
An AE is any untoward medical occurrence in a participant administered a pharmaceutical product that does not necessarily have to have a causal relationship with this treatment.
Group
Value
95% CI
CB-183,315
3.7
Vancomycin
3.0
Adverse events — posted to ClinicalTrials.gov
Time frame: All AEs were collected up to Day 13; only serious AEs (SAEs) and drug-related AEs were collected up to Day 50..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT01085591 — Study of CB-183,315 in Participants With Clostridium Difficile Infection
· Phase 2
· completed
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Other Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) trials
Trials by the same sponsor.
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· Phase 1
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NCT02266706 — Pharmacokinetic and Safety Study of Ceftolozane/Tazobactam in Pediatric Participants Receiving Antibiotic Therapy for Pr
· Phase 1
· completed
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· completed
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Last refreshed: 22 August 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01598311.