A Study of MK-3415, MK-6072, and MK-3415A in Participants Receiving Antibiotic Therapy for Clostridium Difficile Infection (MK-3415A-001) (MODIFY I)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01241552
First received: November 12, 2010
Last updated: October 24, 2016
Last verified: May 2016
Results First Received: October 24, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Clostridium Difficile Infection
Interventions: Biological: MK-3415
Biological: MK-6072
Biological: MK-3415A
Biological: Placebo
Drug: SOC

  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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants 18 years of age or older, with a diagnosis of Clostridium difficile Infection (CDI) were enrolled in this trial.

Reporting Groups
  Description
MK-3415 + SOC Single intravenous (IV) infusion of 10 mg/kg MK-3415 + Standard of Care (SOC) for CDI
MK-6072 + SOC Single IV infusion of 10 mg/kg MK-6072 + Standard of Care for CDI
MK-3415A + SOC Single IV infusion of 10 mg/kg MK-3415A + Standard of Care for CDI
Placebo + SOC Normal saline infusion (0.9% sodium chloride) + Standard of Care for CDI

Participant Flow:   Overall Study
    MK-3415 + SOC   MK-6072 + SOC   MK-3415A + SOC   Placebo + SOC
STARTED   242   403   403   404 
Treated   235   392   388   397 
COMPLETED   201   340   343   340 
NOT COMPLETED   41   63   60   64 
Lack of Efficacy                1                0                0                0 
Death                26                30                20                25 
Adverse Event                1                1                0                0 
Technical Problems                2                0                2                2 
Progressive Disease                0                0                1                2 
Protocol Violation                0                2                6                1 
Withdrawal by Subject                7                15                14                15 
Physician Decision                2                4                2                3 
Lost to Follow-up                2                11                15                16 



  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.
No text entered.

Reporting Groups
  Description
MK-3415 + SOC Single intravenous (IV) infusion of 10 mg/kg MK-3415 + Standard of Care for CDI
MK-6072 + SOC Single IV infusion of 10 mg/kg MK-6072 + Standard of Care for CDI
MK-3415A + SOC Single IV infusion of 10 mg/kg MK-3415A + Standard of Care for CDI
Placebo + SOC Normal saline infusion (0.9% sodium chloride) + Standard of Care for CDI
Total Total of all reporting groups

Baseline Measures
   MK-3415 + SOC   MK-6072 + SOC   MK-3415A + SOC   Placebo + SOC   Total 
Overall Participants Analyzed 
[Units: Participants]
 242   403   403   404   1452 
Age 
[Units: Years]
Mean (Standard Deviation)
 64.2  (16.8)   61.1  (18.5)   62.5  (17.8)   62.9  (18.3)   62.5  (18.0) 
Gender 
[Units: Participants]
Count of Participants
         
Female      137  56.6%      238  59.1%      224  55.6%      230  56.9%      829  57.1% 
Male      105  43.4%      165  40.9%      179  44.4%      174  43.1%      623  42.9% 


  Outcome Measures
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1.  Primary:   Percentage of Participants With Clostridium Difficile Infection (CDI) Recurrence   [ Time Frame: Up to 12 weeks ]

2.  Primary:   Percentage of Participants With One or More Adverse Events (AEs) During 4 Weeks Following Infusion   [ Time Frame: Up to 28 days ]

3.  Primary:   Percentage of Participants With Any Drug-related AE During 4 Weeks Following Infusion   [ Time Frame: Up to 28 days ]

4.  Primary:   Percentage of Participants With Any Serious Adverse Events (SAEs) During 4 Weeks Following Infusion   [ Time Frame: Up to 28 days ]

5.  Primary:   Percentage of Participants With Any Serious Drug-related Adverse Events During 4 Weeks Following Infusion   [ Time Frame: Up to 28 days ]

6.  Primary:   Percentage of Participants Who Discontinued Study Medication Due to an AE During 4 Weeks Following Infusion   [ Time Frame: Up to 28 days ]

7.  Primary:   Percentage of Participants With Infusion-specific AEs   [ Time Frame: Up to 24 hours ]

8.  Secondary:   Percentage of Participants With Global Cure   [ Time Frame: Up to 12 weeks ]

9.  Secondary:   Percentage of Participants With CDI Recurrence in Those With Clinical Cure of the Initial CDI Episode   [ Time Frame: Up to 12 weeks ]

10.  Secondary:   Percentage of Participants ≥ 65 Years of Age at Study Entry With CDI Recurrence   [ Time Frame: Up to 12 weeks ]

11.  Secondary:   Percentage of Participants With a History of CDI in the 6 Months Prior to Enrollment With CDI Recurrence   [ Time Frame: Up to 12 weeks ]

12.  Secondary:   Percentage of Participants With Clinically Severe CDI at Study Entry With CDI Recurrence   [ Time Frame: Up to 12 weeks ]

13.  Secondary:   Percentage of Participants With the B1/NAP1/027 Strain of C. Difficile at Study Entry With CDI Recurrence   [ Time Frame: Up to 12 weeks ]

14.  Secondary:   Percentage of Participants With an Epidemic Strain of C. Difficile (Ribotypes 027, 014, 002, 001, 106, and 020) at Study Entry With CDI Recurrence   [ Time Frame: Up to 12 weeks ]

15.  Secondary:   Percentage of Participants With Compromised Immunity at Study Entry With CDI Recurrence   [ Time Frame: Up to 12 weeks ]


  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: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp.
phone: 1-800-672-6372
e-mail: ClinicalTrialsDisclosure@merck.com



Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01241552     History of Changes
Other Study ID Numbers: 3415A-001
Study First Received: November 12, 2010
Results First Received: October 24, 2016
Last Updated: October 24, 2016