Adults 18 to 90, 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 With a Clinical Outcome of Cure at the End of Treatment (EOT)Primary· Up to 13 days
A clinical outcome of cure at EOT was determined by resolution of diarrhea, defined as ≤ 2 loose stools per 24-hour period for at least 2 consecutive days and the lack of need for additional antibiotics to treat the current CDAD episode after completion of the study treatment period. Participants requiring a collection device were considered to have resolution of diarrhea when the volume of stool (over a 24-hour period) was decreased by 75% as compared to baseline or the participant was no longer passing liquid stool. The estimated adjusted percentage was a weighted average across all strata,
Group
Value
95% CI
Surotomycin
79.0
73.9 – 83.2
Vancomycin
83.6
78.8 – 87.4
Number of Participants With Clinical Response Over TimeSecondary· Up to Day 41
Clinical response over time as measured by those without treatment failure, recurrence, death, or lost to follow-up, measured as the number of participants without failure events (survivors) through the end of therapy (reported for Day 14) and from end of therapy to Day 40 (reported for Day 41).
Day 14
Group
Value
95% CI
Surotomycin
227
Vancomycin
231
Day 41
Group
Value
95% CI
Surotomycin
147
Vancomycin
151
Adjusted Percentage of Participants With Sustained Clinical Response at the End of StudySecondary· Up to Day 50
Sustained clinical response at the end of study was achieved by participants who had a clinical outcome of cure at the end of treatment (Days 40-50) and did not experience a recurrence of CDAD, did not die, were not lost to follow-up, and did not have end of study visit prior to Day 40. The estimated adjusted percentage was a weighted average across all strata, constructed using MRc stratum weights.
Group
Value
95% CI
Surotomycin
60.6
55.0 – 66.0
Vancomycin
61.4
55.9 – 66.8
Percentage of Participants With at Least One Adverse Event (AE)Primary· Up to Day 50
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. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product. AEs may be new events or may be pre-existing conditions that have become aggravated or have worsened in severity or frequency; or may be clinically significant changes from baseline in physic
Group
Value
95% CI
Surotomycin
48.5
Vancomycin
55.2
Percentage of Participants With at Least One Serious Adverse Event (SAE)Primary· Up to Day 50
A SAE is any adverse experience occurring at any dose that results in any of the following outcomes: death; a life-threatening experience, referring to a situation in which the participant was at risk of death at the time of the event, requires in-patient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability or incapacity; is a congenital anomaly or birth defect; or is considered to be an important medical event.
Group
Value
95% CI
Surotomycin
14.4
Vancomycin
12.9
Percentage of Participants Who Discontinued Treatment Due to an AEPrimary· Up to Day 13
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. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product. AEs may be new events or may be pre-existing conditions that have become aggravated or have worsened in severity or frequency; or may be clinically significant changes from baseline in physic
Group
Value
95% CI
Surotomycin
5.6
Vancomycin
2.8
Adjusted Percentage of Participants With Sustained Clinical Response at Day 24Secondary· Day 24
Sustained clinical response at Day 24 was defined as participants who had a clinical outcome of cure at Day 24, who did not experience a recurrence of CDAD, did not die, were not lost to follow-up. Only the first failure event was counted per participant. The estimated adjusted percentage was a weighted average across all strata, constructed using MRc stratum weights.
Group
Value
95% CI
Surotomycin
66.6
61.1 – 71.8
Vancomycin
66.1
60.5 – 71.3
Adjusted Percentage of Participants With Recurrence of CDAD at End of StudySecondary· Up to Day 50
Participants with recurrences were defined as those who were cured at the end of therapy and had a recurrence or were lost to follow-up, died or had a Day 40 -50 contact prior to Day 40. The estimated adjusted percentage was a weighted average across all strata, constructed using MRc stratum weights.
Group
Value
95% CI
Surotomycin
17.7
13.8 – 22.4
Vancomycin
21.2
16.9 – 26.1
Time to Resolution of DiarrheaSecondary· Up to Day 13
Time to resolution of diarrhea with =\< 2 unformed bowel movements (UBM) per 24-hour period was calculated as the date/time of last UBM minus the date/time of the first dose of study drug.
Group
Value
95% CI
Surotomycin
2.8
2.2 – 3.3
Vancomycin
3.0
2.2 – 3.3
Time to Reappearance of Diarrhea From End of Treatment to the End of StudySecondary· Up to Day 50
Time to reappearance of diarrhea with \>= 3 UBM per 24-hour period was calculated as the last date/time of study drug dose to the date/time of first reappearance of 3 or more UBMs among participants who were cured at end of treatment.
Group
Value
95% CI
Surotomycin
NA
NA – NA
Vancomycin
NA
NA – NA
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 BaselineSecondary· Up to Day 13
Clinical response corresponded to a clinical outcome of cure at the end of treatment, and was achieved by participants with infections deemed to be caused by the C. difficile BI/NAP1/027 strain at baseline, who did not fail treatment, did not die, or were not lost to follow-up at the end of treatment. The estimated adjusted percentage was a weighted average across all strata, constructed using MRc stratum weights.
Group
Value
95% CI
Surotomycin
88.5
75.8 – 92.4
Vancomycin
86.3
76.2 – 92.6
Adjusted Percentage of Participants Per Protocol 1 Population With a Clinical Response at the End of TreatmentSecondary· Up to Day 13
Clinical response corresponded to a clinical outcome of cure at the end of treatment, and was achieved by participants who did not fail treatment, did not die, or were not lost to follow-up at the end of treatment. The estimated adjusted percentage was a weighted average across all strata, constructed using MRc stratum weights.
Group
Value
95% CI
Surotomycin
89.1
84.5 – 92.2
Vancomycin
91.5
87.2 – 94.3
Adverse events — posted to ClinicalTrials.gov
Time frame: All AEs were collected up to Day 13; only SAEs and drug related AEs were collected thereafter 30 days after end of treatment (up to Day 50).
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
Other recruiting trials for Clostridium Difficile Infection
Currently open trials in the same condition.
NCT07221370 — Enteral Vancomycin as Primary Prophylaxis Against Clostridioides Difficile Infection in Critically Ill Patients
· Phase 2, PHASE3
· recruiting
NCT06703918 — Study on Clostridium Difficile Infection in Infants
· recruiting
NCT04305769 — Alanyl-glutamine Supplementation for C. Difficile Treatment (ACT)
· Phase 2
· recruiting
NCT04014413 — Safety and Efficacy of Fecal Microbiota Transplantation
· NA
· recruiting
NCT03562741 — Outcomes and Data Collection for Fecal Microbiota Transplantation for the Treatment of Recurrent Clostridium Difficile
· NA
· recruiting
Other Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) trials
Trials by the same sponsor.
NCT02276482 — Study of Tedizolid Phosphate in Adolescents With Complicated Skin and Soft Tissue Infection (cSSTI) (MK-1986-012)
· Phase 3
· completed
NCT02387372 — Plasma Pharmacokinetics (PK) & Lung Penetration of Ceftolozane/Tazobactam in Participants With Pneumonia (MK-7625A-007)
· Phase 1
· completed
NCT02341599 — Study of Pharmacokinetics of a Single IV Dose of CB-238,618 in Subjects With Varying Degrees of Renal Impairment Compare
· Phase 1
· completed
NCT02266706 — Pharmacokinetic and Safety Study of Ceftolozane/Tazobactam in Pediatric Participants Receiving Antibiotic Therapy for Pr
· Phase 1
· completed
NCT02070757 — Safety and Efficacy Study of Ceftolozane/Tazobactam to Treat Ventilated Nosocomial Pneumonia (MK-7625A-008)
· Phase 3
· 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: 23 July 2019
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/NCT01597505.