ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 3 for:    cubist | diarrhea
Previous Study | Return to List | Next Study

Study of CB-183,315 in Participants With Clostridium Difficile Associated Diarrhea (MK-4261-005)

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.
ClinicalTrials.gov Identifier: NCT01597505
Recruitment Status : Completed
First Posted : May 14, 2012
Results First Posted : February 28, 2018
Last Update Posted : February 28, 2018
Sponsor:
Information provided by (Responsible Party):
Cubist Pharmaceuticals LLC

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Clostridium Difficile Infection
Interventions: Drug: Surotomycin
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
Males and females aged 18 years or older with diarrhea at risk for Clostridium Difficile Associated Diarrhea (CDAD) were enrolled in this study

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

Reporting Groups
  Description
Surotomycin 250 mg Surotomycin over encapsulated tablet administered orally, twice daily for a daily total dose of 500 mg; and Placebo over encapsulated tablet administered orally, twice daily for 10 days
Vancomycin 125 mg Vancomycin over-encapsulated capsule administered orally, four times daily for a daily total dose of 500 mg, for 10 days

Participant Flow:   Overall Study
    Surotomycin   Vancomycin
STARTED   308 [1]   298 [1] 
Treated   305 [2]   286 
COMPLETED   264   265 
NOT COMPLETED   44   33 
Physician Decision                5                0 
Adverse Event                19                7 
Lost to Follow-up                4                2 
Withdrawal by Subject                10                18 
Other                5                6 
Missing                1                0 
[1] Randomized participants
[2] One participant was instead randomized to vancomycin



  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.
No text entered.

Reporting Groups
  Description
Surotomycin 250 mg Surotomycin over encapsulated tablet administered orally, twice daily for a daily total dose of 500 mg; and Placebo over encapsulated tablet administered orally, twice daily for 10 days
Vancomycin 125 mg Vancomycin over-encapsulated capsule administered orally, four times daily for a daily total dose of 500 mg, for 10 days
Total Total of all reporting groups

Baseline Measures
   Surotomycin   Vancomycin   Total 
Overall Participants Analyzed 
[Units: Participants]
 308   298   606 
Age 
[Units: Years]
Mean (Standard Deviation)
     
Participants Analyzed   308   298   606 
   61.5  (17.5)   61.8  (18.4)   61.6  (17.9) 
Age, Customized [1] [2] 
[Units: Participants]
     
< 75 years old       
Participants Analyzed   290   280   570 
< 75 years old   211   200   411 
>= 75 years old       
Participants Analyzed   290   280   570 
>= 75 years old   79   80   159 
[1] Number of participants <75 or >=75 years old at First Dose
[2] Randomized participants with Confirmed CDAD
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Participants Analyzed   308   298   606 
Female      185  60.1%      175  58.7%      360  59.4% 
Male      123  39.9%      123  41.3%      246  40.6% 
Previous episodes of CDAD [1] [2] 
[Units: Participants]
     
0 Previous Episodes       
Participants Analyzed   286   275   561 
0 Previous Episodes   237   224   461 
>= 1 Previous Episodes       
Participants Analyzed   286   275   561 
>= 1 Previous Episodes   49   51   100 
[1] Number of participants with previous episodes of CDAD
[2] Randomized participants with Confirmed CDAD evaluated for previous episodes of CDAD
BI/NAP1/027 Strain [1] [2] 
[Units: Participants]
     
With BI/NAP1/027 Strain       
Participants Analyzed   255   246   501 
With BI/NAP1/027 Strain   59   67   126 
Without BI/NAP1/027 Strain       
Participants Analyzed   255   246   501 
Without BI/NAP1/027 Strain   196   179   375 
[1] Number of participants with the BI/NAP1/027 Strain
[2] Randomized participants with Confirmed CDAD evaluated for BI/NAP1/027 Strain


  Outcome Measures

1.  Primary:   Adjusted Percentage of Participants With a Clinical Outcome of Cure at the End of Treatment (EOT)   [ Time Frame: Up to 13 days ]

2.  Primary:   Percentage of Participants With at Least One Adverse Event (AE)   [ Time Frame: Up to Day 50 ]

3.  Primary:   Percentage of Participants With at Least One Serious Adverse Event (SAE)   [ Time Frame: Up to Day 50 ]

4.  Primary:   Percentage of Participants Who Discontinued Treatment Due to an AE   [ Time Frame: Up to Day 13 ]

5.  Secondary:   Number of Participants With Clinical Response Over Time   [ Time Frame: Up to Day 41 ]

6.  Secondary:   Adjusted Percentage of Participants With Sustained Clinical Response at the End of Study   [ Time Frame: Up to Day 50 ]

7.  Secondary:   Adjusted Percentage of Participants With Sustained Clinical Response at Day 24   [ Time Frame: Day 24 ]

8.  Secondary:   Adjusted Percentage of Participants With Recurrence of CDAD at End of Study   [ Time Frame: Up to Day 50 ]

9.  Secondary:   Time to Resolution of Diarrhea   [ Time Frame: Up to Day 13 ]

10.  Secondary:   Time to Reappearance of Diarrhea From End of Treatment to the End of Study   [ Time Frame: Up to Day 50 ]

11.  Secondary:   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 Baseline   [ Time Frame: Up to Day 13 ]

12.  Secondary:   Adjusted Percentage of Participants Per Protocol 1 Population With a Clinical Response at the End of Treatment   [ Time Frame: Up to Day 13 ]

13.  Secondary:   Adjusted Percentage of Participants With a Sustained Clinical Response at the End of Study for Infections Deemed to be Caused by the C. Difficile BI/NAP1/027 Strain at Baseline   [ Time Frame: Up to Day 50 ]

14.  Secondary:   Adjusted Percentage of Participants From the Per Protocol 2 Population With a Sustained Clinical Response at the End of Study   [ Time Frame: 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
No text entered.


  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
e-mail: ClinicalTrialsDisclosure@merck.com


Publications of Results:
Boix V, Fedorak RN, Mullane KM, Pesant Y, Stoutenburgh U, Jin M, Adedoyin A, Chesnel L, Guris D, Larson KB, Murata Y. Primary outcomes from a phase 3, randomized, double-blind, active-controlled trial of surotomycin in subjects with Clostridium difficile infection. Open Forum Infect Dis. 2017;4(1):ofw275. doi: 10.1093/ofid/ofw275


Responsible Party: Cubist Pharmaceuticals LLC
ClinicalTrials.gov Identifier: NCT01597505     History of Changes
Other Study ID Numbers: 4261-005
LCD-CDAD-10-07 ( Other Identifier: Cubist Study Number )
MK-4261-005 ( Other Identifier: Merck Protocol Number )
2012-000252-34 ( EudraCT Number )
First Submitted: May 10, 2012
First Posted: May 14, 2012
Results First Submitted: January 18, 2018
Results First Posted: February 28, 2018
Last Update Posted: February 28, 2018