Study of CB-183,315 in Participants With Clostridium Difficile Infection

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Cubist Pharmaceuticals Holdings LLC
ClinicalTrials.gov Identifier:
NCT01085591
First received: March 9, 2010
Last updated: June 12, 2015
Last verified: June 2015
Results First Received: April 21, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Clostridium Difficile Infection
Diarrhea
Interventions: Drug: CB-183,315
Drug: Placebo
Drug: Vancomycin

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
CB-183,315, 125 mg 125 milligrams (mg) CB-183,315 administered orally twice daily, alternating with twice daily oral administration of placebo tablets, for 10 days
CB-183,315, 250 mg 250 mg CB-183,315 administered orally twice daily, alternating with twice daily oral administration of placebo tablets, for 10 days.
Oral Vancomycin, 125 mg 125 mg vancomycin administered orally four times a day for 10 days

Participant Flow:   Overall Study
    CB-183,315, 125 mg     CB-183,315, 250 mg     Oral Vancomycin, 125 mg  
STARTED     69     71     70  
Received at Least 1 Dose of Study Drug     68     69     70  
COMPLETED     66     65     63  
NOT COMPLETED     3     6     7  
Adverse Event                 0                 1                 3  
Physician Decision                 1                 0                 1  
Withdrawal by Subject                 0                 2                 1  
Lost to Follow-up                 0                 1                 1  
Protocol Violation                 1                 1                 1  
Unknown                 0                 1                 0  
Not Properly Consented                 1                 0                 0  



  Baseline Characteristics
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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.
All randomized participants who gave proper informed consent.

Reporting Groups
  Description
CB-183,315, 125 mg 125 milligrams (mg) CB-183,315 administered orally twice daily, alternating with twice daily oral administration of placebo tablets, for 10 days
CB-183,315, 250 mg 250 mg CB-183,315 administered orally twice daily, alternating with twice daily oral administration of placebo tablets, for 10 days.
Oral Vancomycin, 125 mg 125 mg vancomycin administered orally four times a day for 10 days
Total Total of all reporting groups

Baseline Measures
    CB-183,315, 125 mg     CB-183,315, 250 mg     Oral Vancomycin, 125 mg     Total  
Number of Participants  
[units: participants]
  68     71     70     209  
Age  
[units: participants]
       
<=18 years     0     0     0     0  
Between 18 and 65 years     47     43     40     130  
>=65 years     21     28     30     79  
Gender  
[units: participants]
       
Female     45     43     44     132  
Male     23     28     26     77  



  Outcome Measures
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1.  Primary:   Number of Participants With a Clinical Response Outcome of Clostridium Difficile Infection Cure at the End of Study Treatment   [ Time Frame: Baseline (Day 0) through Study Day 19 ]

2.  Primary:   Number of Participants With a Clinical Response Outcome of Failure or Unable to Evaluate at the End of Study Treatment   [ Time Frame: Baseline (Day 0) through Study Day 19 ]

3.  Secondary:   Number of Participants With a Recurrence of Clostridium Difficile Infection Through the 4-week Follow-up Period   [ Time Frame: Study Day 10 up to Study Day 40 ]

4.  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   [ Time Frame: Baseline (Day 0) through Study Day 12 ]

5.  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   [ Time Frame: Study Day 10 up to Study Day 40 ]

6.  Secondary:   Median Time to Resolution of Diarrhea   [ Time Frame: Baseline (Day 0) through Study Day 12 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Vice President, Clinical Research
Organization: Cubist Pharmaceuticals, Inc.
phone: 1.781.860.8660


No publications provided


Responsible Party: Cubist Pharmaceuticals Holdings LLC
ClinicalTrials.gov Identifier: NCT01085591     History of Changes
Other Study ID Numbers: LCD-DR-09-03
Study First Received: March 9, 2010
Results First Received: April 21, 2015
Last Updated: June 12, 2015
Health Authority: United States: Food and Drug Administration