Trial · NCT01597505
Study of CB-183,315 in Participants With Clostridium Difficile Associated Diarrhea (MK-4261-005)
NCT01597505, Phase 3, Completed, Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA); results first posted 2018-02-28
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Study of CB-183,315 in Participants With Clostridium Difficile Associated Diarrhea (MK-4261-005). Trials, record NCT01597505. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01597505
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of CB-183,315 in Participants With Clostridium Difficile Associated Diarrhea (MK-4261-005)
- NCT number
- NCT01597505
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 606 participants, actual
- Lead sponsor
- Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
- Conditions
- Clostridium Difficile Infection
- Interventions
- Surotomycin, Vancomycin, Placebo
- First posted
- 2012-05-14
- Last updated
- 2019-07-23
- Other registries' IDs
- eudract:2012-000252-34
- Results first posted
- 2018-02-28
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Adjusted Percentage of Participants With a Clinical Outcome of Cure at the End of Treatment (EOT) | 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, constructed using Mehrotra-Railkar continuity-corrected minimum risk (MRc) stratum weights. |
| Primary | Percentage of Participants With at Least One Adverse Event (AE) | 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 physical examination, laboratory tests, or other diagnostic investigation (e.g. laboratory results, x-ray findings). |
| Primary | Percentage of Participants With at Least One Serious Adverse Event (SAE) | 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. |
| Primary | Percentage of Participants Who Discontinued Treatment Due to an AE | 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 physical examination, laboratory tests, or other diagnostic investigation (e.g. laboratory results, x-ray findings). |
| Secondary | Number of Participants With Clinical Response Over Time | 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). |
| Secondary | Adjusted Percentage of Participants With Sustained Clinical Response at the End of Study | 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. |
| Secondary | Adjusted Percentage of Participants With Sustained Clinical Response at Day 24 | 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. |
| Secondary | Adjusted Percentage of Participants With Recurrence of CDAD at End of Study | 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. |
| Secondary | Time to Resolution of Diarrhea | 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. |
| Secondary | Time to Reappearance of Diarrhea From End of Treatment to the End of Study | 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. |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 registered outcomesOutcomes14
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Adjusted Percentage of Participants With a Clinical Outcome of Cure at the End of Treatment (EOT) | Up to 13 days | The population analyzed is the Microbiological Modified Intent-To-Treat (mMITT) population consisting of all randomized participants who had a confirmed diagnosis of CDAD regardless of whether they received any amount of study drug, based on the treatment to which they were randomized. | Percentage of participants | NUMBER |
| SECONDARY | Number of Participants With Clinical Response Over Time | Up to Day 41 | The mMITT population consisting of all randomized participants who had a confirmed diagnosis of CDAD regardless of whether they received any amount of study drug, based on the treatment to which they were randomized | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Adjusted Percentage of Participants With Sustained Clinical Response at the End of Study | Up to Day 50 | The mMITT population consisting of all randomized participants who had a confirmed diagnosis of CDAD regardless of whether they received any amount of study drug, based on the treatment to which they were randomized. | Percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants With at Least One Adverse Event (AE) | Up to Day 50 | All randomized participants who received any amount of study drug | Percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants With at Least One Serious Adverse Event (SAE) | Up to Day 50 | All randomized participants who received any amount of study drug | Percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants Who Discontinued Treatment Due to an AE | Up to Day 13 | All randomized participants who received any amount of study drug | Percentage of participants | NUMBER |
| SECONDARY | Adjusted Percentage of Participants With Sustained Clinical Response at Day 24 | Day 24 | The mMITT population consisting of all randomized participants who had a confirmed diagnosis of CDAD regardless of whether they received any amount of study drug, based on the treatment to which they were randomized. | Percentage of participants | NUMBER |
| SECONDARY | Adjusted Percentage of Participants With Recurrence of CDAD at End of Study | Up to Day 50 | The mMITT population consisting of all randomized participants who had a confirmed diagnosis of CDAD regardless of whether they received any amount of study drug, based on the treatment to which they were randomized. | Percentage of participants | NUMBER |
| SECONDARY | Time to Resolution of Diarrhea | Up to Day 13 | The mMITT population consisting of all randomized participants who had a confirmed diagnosis of CDAD regardless of whether they received any amount of study drug, based on the treatment to which they were randomized | Days | MEDIAN |
| SECONDARY | Time to Reappearance of Diarrhea From End of Treatment to the End of Study | Up to Day 50 | The mMITT population consisting of all randomized participants who had a confirmed diagnosis of CDAD regardless of whether they received any amount of study drug, based on the treatment to which they were randomized; and were cured at end of treatment. | Days | MEDIAN |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 outcomesResults by group30
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Adjusted Percentage of Participants With a Clinical Outcome of Cure at the End of Treatment (EOT) | Surotomycin | 79.0 | 95% Confidence Interval 73.9 to 83.2 | Percentage of participants | |
| Adjusted Percentage of Participants With a Clinical Outcome of Cure at the End of Treatment (EOT) | Vancomycin | 83.6 | 95% Confidence Interval 78.8 to 87.4 | Percentage of participants | |
| Number of Participants With Clinical Response Over Time | Surotomycin | Day 14 | 227 | Participants | |
| Number of Participants With Clinical Response Over Time | Vancomycin | Day 14 | 231 | Participants | |
| Number of Participants With Clinical Response Over Time | Surotomycin | Day 41 | 147 | Participants | |
| Number of Participants With Clinical Response Over Time | Vancomycin | Day 41 | 151 | Participants | |
| Adjusted Percentage of Participants With Sustained Clinical Response at the End of Study | Surotomycin | 60.6 | 95% Confidence Interval 55.0 to 66.0 | Percentage of participants | |
| Adjusted Percentage of Participants With Sustained Clinical Response at the End of Study | Vancomycin | 61.4 | 95% Confidence Interval 55.9 to 66.8 | Percentage of participants | |
| Percentage of Participants With at Least One Adverse Event (AE) | Surotomycin | 48.5 | Percentage of participants | ||
| Percentage of Participants With at Least One Adverse Event (AE) | Vancomycin | 55.2 | Percentage of participants |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Surotomycin | 308 | |
| Overall Study | STARTED | Vancomycin | 298 | |
| Overall Study | Treated | Surotomycin | 305 | |
| Overall Study | Treated | Vancomycin | 286 | |
| Overall Study | COMPLETED | Surotomycin | 264 | |
| Overall Study | COMPLETED | Vancomycin | 265 | |
| Overall Study | NOT COMPLETED | Surotomycin | 44 | |
| Overall Study | NOT COMPLETED | Vancomycin | 33 |
Source ClinicalTrials.gov
Adverse events172
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Abdominal pain | Gastrointestinal disorders | Surotomycin | 16 | 305 | 20 |
| other | Abdominal pain | Gastrointestinal disorders | Vancomycin | 6 | 286 | 6 |
| other | Nausea | Gastrointestinal disorders | Surotomycin | 20 | 305 | 23 |
| other | Nausea | Gastrointestinal disorders | Vancomycin | 21 | 286 | 21 |
| other | Headache | Nervous system disorders | Surotomycin | 12 | 305 | 13 |
| other | Headache | Nervous system disorders | Vancomycin | 18 | 286 | 21 |
| serious | Anaemia | Blood and lymphatic system disorders | Surotomycin | 3 | 305 | 3 |
| serious | Anaemia | Blood and lymphatic system disorders | Vancomycin | 0 | 286 | 0 |
| serious | Febrile neutropenia | Blood and lymphatic system disorders | Surotomycin | 0 | 305 | 0 |
| serious | Febrile neutropenia | Blood and lymphatic system disorders | Vancomycin | 1 | 286 | 1 |
1 to 10 of 172Source ClinicalTrials.gov
See all 172 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Surotomycin | 18 | 305 |
| Total, all-cause mortality | Vancomycin | 9 | 286 |
| Total, other adverse events | Surotomycin | 38 | 305 |
| Total, other adverse events | Vancomycin | 38 | 286 |
| Total, serious adverse events | Surotomycin | 44 | 305 |
| Total, serious adverse events | Vancomycin | 37 | 286 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Surotomycin vs Vancomycin: deaths from any cause | Trial comparisons |
| Surotomycin vs Vancomycin: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01597505
GET https://conductscience.org/api/trials/v1/NCT01597505/results?page=2