Trial · NCT01085591
Study of CB-183,315 in Participants With Clostridium Difficile Infection
NCT01085591, Phase 2, Completed, Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA); results first posted 2015-06-16
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ConductScience Library. Study of CB-183,315 in Participants With Clostridium Difficile Infection. Trials, record NCT01085591. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01085591
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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 Infection
- NCT number
- NCT01085591
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 210 participants, actual
- Lead sponsor
- Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
- Conditions
- Clostridium Difficile Infection, Diarrhea
- Interventions
- CB-183,315, Placebo, Vancomycin
- First posted
- 2010-03-12
- Last updated
- 2018-09-11
- Results first posted
- 2015-06-16
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With a Clinical Response Outcome of Clostridium Difficile Infection Cure at the End of Study Treatment | Baseline (Day 0) through Study Day 19 | The number of participants with an Investigator-assessed clinical response of cure is presented. The information to assess clinical response was collected at any time up to and including Day 19. |
| Primary | Number of Participants With a Clinical Response Outcome of Failure or Unable to Evaluate at the End of Study Treatment | Baseline (Day 0) through Study Day 19 | The number of participants with investigator assessed clinical response of failure or unable to evaluate is presented. Clinical response was determined by the participant's condition on the second day following the last dose of study medication, unless considered a treatment failure. Treatment failures were assessed whenever they occurred and were carried forward to the end-of-treatment (EOT). The information to assess clinical response was collected at any time up to and including Day 19. |
| Secondary | Number of Participants With a Recurrence of Clostridium Difficile Infection Through the 4-week Follow-up Period | Study Day 10 up to Study Day 40 | The number of participants with a recurrence of CDI is presented along with the number of participants without a recurrence and who were unable to be evaluated. Participants with a favorable outcome at the EOT (cure) were evaluated for recurrence of CDI. Only subjects deemed a cure at EOT were assessed for recurrence. This is the denominator used for all percentages. If diarrheal symptoms returned, participants were asked to indicate the number of unformed bowel movements (UBM) they had and have an additional C. difficile toxin test. The information to assess recurrence in participants who were deemed a cure at EOT was collected at any time during the 4-week Follow-up Period (FUP). |
| Secondary | Number of Participants With a Clinical Response Outcome at the End of Study Treatment With and Without Infection Caused by C. Difficile BI/NAP1/027 Strain at Baseline | Baseline (Day 0) through Study Day 12 | The number of participants with investigator assessed clinical response of cure, failure or unable to evaluate is presented and shown separately for participants with and without infection caused by C. difficile BI/NAP1/027 strain as determined at baseline. Clinical response was determined by the participant's condition on the second day following the last dose of study medication, unless considered a treatment failure. Treatment failures were assessed whenever they occurred and were carried forward to the EOT. The information to assess clinical response for infection caused by C. difficile BI/NAP1/027 strain at Baseline was collected at any time up to and including Day 12. Strain at Baseline=SAB |
| Secondary | Number of Participants With a Recurrence of Clostridium Difficile Infection at the End of Study Treatment With and Without Infection Caused by C. Difficile BI/NAP1/027 Strain at Baseline | Study Day 10 up to Study Day 40 | The number of participants with and without infection caused by C. difficile BI/NAP1/027 strain as determined at baseline with a recurrence of CDI is presented along with the number of participants without a recurrence and who were unable to be evaluated. Participants with a favorable outcome at the EOT (cure) were evaluated for recurrence of CDI. If diarrheal symptoms returned, participants were asked to indicate the number of UBM they had and have an additional C. difficile toxin test. The information to assess recurrence in participants who were deemed a cure at EOT was collected at any time during the 4-week FUP. Strain at Baseline=SAB. |
| Secondary | Median Time to Resolution of Diarrhea | Baseline (Day 0) through Study Day 12 | The median time to resolution of diarrhea is presented for evaluable participants in each treatment group. The time in days from the start of treatment (time of first dose of study drug) to resolution (time of the last UBM on the day before the first of 2 consecutive days of \< 4 UBMs and sustained through the second day following the last dose of study drug). |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With a Clinical Response Outcome of Clostridium Difficile Infection Cure at the End of Study Treatment | Baseline (Day 0) through Study Day 19 | All participants who received any amount of study drug and had a confirmed diagnosis of Clostridium difficile infection (CDI). | participants | NUMBER |
| SECONDARY | Number of Participants With a Recurrence of Clostridium Difficile Infection Through the 4-week Follow-up Period | Study Day 10 up to Study Day 40 | All participants who received any amount of study drug and had a confirmed diagnosis of Clostridium difficile infection (CDI). | Participants | NUMBER |
| SECONDARY | Number of Participants With a Clinical Response Outcome at the End of Study Treatment With and Without Infection Caused by C. Difficile BI/NAP1/027 Strain at Baseline | Baseline (Day 0) through Study Day 12 | All participants who received any amount of study drug and had a confirmed diagnosis of Clostridium difficile infection (CDI). | participants | NUMBER |
| SECONDARY | Number of Participants With a Recurrence of Clostridium Difficile Infection at the End of Study Treatment With and Without Infection Caused by C. Difficile BI/NAP1/027 Strain at Baseline | Study Day 10 up to Study Day 40 | All participants who received any amount of study drug and had a confirmed diagnosis of Clostridium difficile infection (CDI). | participants | NUMBER |
| SECONDARY | Median Time to Resolution of Diarrhea | Baseline (Day 0) through Study Day 12 | All participants who received any amount of study drug, had a confirmed diagnosis of Clostridium difficile infection (CDI), and who achieved resolution of their diarrhea. | Days | MEDIAN |
| PRIMARY | Number of Participants With a Clinical Response Outcome of Failure or Unable to Evaluate at the End of Study Treatment | Baseline (Day 0) through Study Day 19 | All participants who received any amount of study drug and had a confirmed diagnosis of Clostridium difficile infection (CDI). | participants | NUMBER |
Source ClinicalTrials.gov
Results by group57
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With a Clinical Response Outcome of Clostridium Difficile Infection Cure at the End of Study Treatment | CB-183,315, 125mg | 61 | participants | ||
| Number of Participants With a Clinical Response Outcome of Clostridium Difficile Infection Cure at the End of Study Treatment | CB-183,315, 250 mg | 58 | participants | ||
| Number of Participants With a Clinical Response Outcome of Clostridium Difficile Infection Cure at the End of Study Treatment | Oral Vancomycin, 125 mg | 59 | participants | ||
| Number of Participants With a Recurrence of Clostridium Difficile Infection Through the 4-week Follow-up Period | CB-183,315, 125 mg | Recurrence of CDI | 17 | Participants | |
| Number of Participants With a Recurrence of Clostridium Difficile Infection Through the 4-week Follow-up Period | CB-183,315, 250 mg | Recurrence of CDI | 10 | Participants | |
| Number of Participants With a Recurrence of Clostridium Difficile Infection Through the 4-week Follow-up Period | Oral Vancomycin, 125 mg | Recurrence of CDI | 21 | Participants | |
| Number of Participants With a Recurrence of Clostridium Difficile Infection Through the 4-week Follow-up Period | CB-183,315, 125 mg | No Recurrence of CDI | 44 | Participants | |
| Number of Participants With a Recurrence of Clostridium Difficile Infection Through the 4-week Follow-up Period | CB-183,315, 250 mg | No Recurrence of CDI | 47 | Participants | |
| Number of Participants With a Recurrence of Clostridium Difficile Infection Through the 4-week Follow-up Period | Oral Vancomycin, 125 mg | No Recurrence of CDI | 37 | Participants | |
| Number of Participants With a Recurrence of Clostridium Difficile Infection Through the 4-week Follow-up Period | CB-183,315, 125 mg | Unable to Evaluate | 0 | Participants |
1 to 10 of 57Source ClinicalTrials.gov
See all 57 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | CB-183,315, 125 mg | 69 | |
| Overall Study | STARTED | CB-183,315, 250 mg | 71 | |
| Overall Study | STARTED | Oral Vancomycin, 125 mg | 70 | |
| Overall Study | Received at Least 1 Dose of Study Drug | CB-183,315, 125 mg | 68 | |
| Overall Study | Received at Least 1 Dose of Study Drug | CB-183,315, 250 mg | 69 | |
| Overall Study | Received at Least 1 Dose of Study Drug | Oral Vancomycin, 125 mg | 70 | |
| Overall Study | COMPLETED | CB-183,315, 125 mg | 66 | |
| Overall Study | COMPLETED | CB-183,315, 250 mg | 65 | |
| Overall Study | COMPLETED | Oral Vancomycin, 125 mg | 63 | |
| Overall Study | NOT COMPLETED | CB-183,315, 125 mg | 3 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events585
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 | Anaemia | Blood and lymphatic system disorders | CB-183,315, 125 mg | 0 | 68 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | CB-183,315, 250 mg | 1 | 69 | 1 |
| other | Anaemia | Blood and lymphatic system disorders | Oral Vancomycin, 125 mg | 1 | 70 | 1 |
| other | Heparin-induced thrombocytopenia | Blood and lymphatic system disorders | CB-183,315, 125 mg | 1 | 68 | 1 |
| other | Heparin-induced thrombocytopenia | Blood and lymphatic system disorders | CB-183,315, 250 mg | 0 | 69 | 0 |
| other | Heparin-induced thrombocytopenia | Blood and lymphatic system disorders | Oral Vancomycin, 125 mg | 0 | 70 | 0 |
| other | Leukocytosis | Blood and lymphatic system disorders | CB-183,315, 125 mg | 0 | 68 | 0 |
| other | Leukocytosis | Blood and lymphatic system disorders | CB-183,315, 250 mg | 0 | 69 | 0 |
| other | Leukocytosis | Blood and lymphatic system disorders | Oral Vancomycin, 125 mg | 1 | 70 | 1 |
| other | Lymphadenopathy | Blood and lymphatic system disorders | CB-183,315, 125 mg | 0 | 68 | 0 |
1 to 10 of 585Source ClinicalTrials.gov
See all 585 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | CB-183,315, 125 mg | ||
| Total, all-cause mortality | CB-183,315, 250 mg | ||
| Total, all-cause mortality | Oral Vancomycin, 125 mg | ||
| Total, other adverse events | CB-183,315, 125 mg | 34 | 68 |
| Total, other adverse events | CB-183,315, 250 mg | 43 | 69 |
| Total, other adverse events | Oral Vancomycin, 125 mg | 41 | 70 |
| Total, serious adverse events | CB-183,315, 125 mg | 12 | 68 |
| Total, serious adverse events | CB-183,315, 250 mg | 6 | 69 |
| Total, serious adverse events | Oral Vancomycin, 125 mg | 11 | 70 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 27432604 | RESULT |
Source PubMed
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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
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