A Study of CB-183,315 in Participants With Clostridium Difficile Associated Diarrhea (MK-4261-006)
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|ClinicalTrials.gov Identifier: NCT01598311|
Recruitment Status : Completed
First Posted : May 15, 2012
Results First Posted : February 27, 2018
Last Update Posted : September 11, 2018
|Condition or disease||Intervention/treatment||Phase|
|Clostridium Difficile Infection||Drug: CB-183,315 Drug: Vancomycin Drug: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||608 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||A Randomized, Double-Blinded, Active-Controlled Study of CB-183,315 in Patients With Clostridium Difficile Associated Diarrhea|
|Actual Study Start Date :||May 16, 2012|
|Actual Primary Completion Date :||July 26, 2015|
|Actual Study Completion Date :||August 25, 2015|
Participants took CB-183,315 250 mg twice daily (b.i.d.) and placebo capsules b.i.d. by mouth for 10 days.
CB-183,315 250 mg white coated tablet over-encapsulated in a size 00 opaque hard gelatin capsule.
Other Name: Surotomycin
Placebo size 00 opaque hard gelatin capsules.
Active Comparator: Vancomycin
Participants took vancomycin 125 mg four times daily (q.i.d.) by mouth for 10 days.
Vancomycin hydrochloride 125 mg capsule over-encapsulated in size 00 opaque hard gelatin capsule.
- Adjusted Percentage of Participants Meeting Clinical Response Criteria for Cure at End of Treatment (EOT) [ Time Frame: 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 neutralization assay. 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 order to calculate the adjusted percentage.
- Percentage of Participants Experiencing an Adverse Event (AE) [ Time Frame: 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.
- Percentage of Participants Discontinuing From Study Treatment Due to an AE [ Time Frame: 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.
- Number of Clinical Failure Events up to Day 40 [ Time Frame: 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.
- Adjusted Percentage of Participants With Sustained Clinical Response at End of Study [ Time Frame: 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 order to calculate the adjusted percentage.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01598311
|Study Director:||Medical Director||Merck Sharp & Dohme Corp.|