A Study of CB-183,315 in Participants With Clostridium Difficile Associated Diarrhea (MK-4261-006)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01598311
Recruitment Status : Completed
First Posted : May 15, 2012
Results First Posted : February 27, 2018
Last Update Posted : March 29, 2018
Information provided by (Responsible Party):
Cubist Pharmaceuticals LLC

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition: Clostridium Difficile Infection
Interventions: Drug: CB-183,315
Drug: Vancomycin
Drug: Placebo

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
This study enrolled adult participants with Clostridium Difficile associated diarrhea (CDAD) at 104 study centers in North America, Asia-Pacific, and South America.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
CB-183,315 Participants took CB-183,315 250 mg twice daily (b.i.d.) and placebo b.i.d. by mouth for 10 days.
Vancomycin Participants took vancomycin 125 mg four times daily (q.i.d.) by mouth for 10 days.

Participant Flow:   Overall Study
    CB-183,315   Vancomycin
STARTED [1]   303   305 
Treated [2]   294   301 
Treated and Confirmed CDAD [3]   285   292 
COMPLETED   256   244 
NOT COMPLETED   47   61 
Physician Decision                4                5 
Adverse Event                9                13 
Lost to Follow-up                7                12 
Withdrawal by Subject                9                13 
No reason provided.                0                5 
Randomized but never treated                8                5 
Treated but no confirmed CDAD                9                8 
Assigned to CB but received vancomycin                1                0 
[1] Randomized
[2] Safety Population
[3] mMITT Population

  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The baseline analysis population includes all randomized and treated participants with a confirmed CDAD diagnosis (microbiological modified intent-to-treat [mMITT] population).

Reporting Groups
CB-183,315 Participants took CB-183,315 250 mg b.i.d. and placebo b.i.d. by mouth for 10 days.
Vancomycin Participants took vancomycin 125 mg q.i.d. by mouth for 10 days.
Total Total of all reporting groups

Baseline Measures
   CB-183,315   Vancomycin   Total 
Overall Participants Analyzed 
[Units: Participants]
 285   292   577 
[Units: Years]
Mean (Standard Deviation)
 57.6  (18.3)   56.5  (18.3)   57.1  (18.3) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
Female      173  60.7%      194  66.4%      367  63.6% 
Male      112  39.3%      98  33.6%      210  36.4% 

  Outcome Measures

1.  Primary:   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) ]

2.  Primary:   Percentage of Participants Experiencing an Adverse Event (AE)   [ Time Frame: Up to 30 days after EOT (up to Day 40) ]

3.  Primary:   Percentage of Participants Discontinuing From Study Treatment Due to an AE   [ Time Frame: Up to EOT (up to Day 10) ]

4.  Secondary:   Number of Clinical Failure Events up to Day 40   [ Time Frame: Up to 30 days after EOT (up to Day 40) ]

5.  Secondary:   Adjusted Percentage of Participants With Sustained Clinical Response at End of Study   [ Time Frame: Up to 40 days after EOT (up to Day 50) ]

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact:  
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp.
phone: 1-800-672-6372

Publications of Results:

Responsible Party: Cubist Pharmaceuticals LLC Identifier: NCT01598311     History of Changes
Other Study ID Numbers: 4261-006
LCD-CDAD-11-06 ( Other Identifier: Cubist Protocol Number )
2012-000252-34 ( EudraCT Number )
MK-4261-006 ( Other Identifier: Merck Protocol Number )
First Submitted: May 10, 2012
First Posted: May 15, 2012
Results First Submitted: January 31, 2018
Results First Posted: February 27, 2018
Last Update Posted: March 29, 2018