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A Study of MK-6072 and MK-3415A in Participants Receiving Antibiotic Therapy for Clostridium Difficile Infection (MK-3415A-002) (MODIFY II)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01513239
First Posted: January 20, 2012
Last Update Posted: March 29, 2017
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.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
Results First Submitted: October 24, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition: Clostridium Difficile Infection
Interventions: 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
Male and female participants 18 years of age or older, diagnosed with Clostridium difficile infection (CDI) and receiving Standard of Care (SOC) therapy were recruited for this trial.

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

Participant Flow:   Overall Study
    MK-3415A + SOC   MK-6072 + SOC   Placebo + SOC
STARTED   397 [1]   407 [1]   399 [1] 
Treated   391 [2]   396 [2]   381 [2] 
All Participants as Treated   390 [3]   396 [4]   381 [4] 
COMPLETED   322   337   311 
NOT COMPLETED   75   70   88 
Adverse Event                1                1                2 
Death                29                22                32 
Lost to Follow-up                11                10                6 
Physician Decision                4                4                4 
Protocol Violation                2                2                2 
Technical Problems                1                2                0 
Withdrawal by Subject                27                29                42 
[1] Randomized participants
[2] Treated participants
[3] One participant randomized to receive MK-3415A (MK-3415 plus MK-6072) received only MK-3415
[4] Treatment actually received



  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

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

Baseline Measures
   MK-3415A + SOC   MK-6072 + SOC   Placebo + SOC   Total 
Overall Participants Analyzed 
[Units: Participants]
 397   407   399   1203 
Age 
[Units: Years]
Mean (Standard Deviation)
 65.9  (17.3)   62.6  (17.5)   64.3  (16.4)   64.2  (17.1) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
       
Female      216  54.4%      220  54.1%      239  59.9%      675  56.1% 
Male      181  45.6%      187  45.9%      160  40.1%      528  43.9% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Percentage of Participants With CDI Recurrence   [ Time Frame: 12 weeks ]

2.  Primary:   Percentage of Participants With One or More Adverse Events During 4 Weeks Following Infusion Treatment   [ Time Frame: Up to 4 weeks ]

3.  Primary:   Percentage of Participants With One or More Drug-related Adverse Events During 4 Weeks Following Infusion Treatment   [ Time Frame: Up to 4 weeks ]

4.  Primary:   Percentage of Participants With One or More Serious Drug-related Adverse Events During 4 Weeks Following Infusion Treatment   [ Time Frame: Up to 4 weeks ]

5.  Primary:   Percentage of Participants Who Discontinued Study Medication Due to an Adverse Event During 4 Weeks Following Infusion Treatment   [ Time Frame: Up to 4 weeks ]

6.  Primary:   Percentage of Participants With One or More Infusion-specific Adverse Events on the Day of Infusion or the Day After Infusion   [ Time Frame: Up to 24 hours ]

7.  Secondary:   Percentage of Participants With Global Cure   [ Time Frame: 12 weeks ]

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

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

10.  Secondary:   Percentage of Participants With CDI Recurrence in Those With the 027 Ribotype   [ Time Frame: 12 weeks ]

11.  Secondary:   Percentage of Participants With CDI Recurrence in Those With an Epidemic Strain   [ Time Frame: 12 weeks ]

12.  Secondary:   Percentage of Participants With CDI Recurrence in Those With Clinically Severe CDI   [ Time Frame: 12 weeks ]

13.  Secondary:   Percentage of Participants With CDI Recurrence in Those 65 Years and Older   [ Time Frame: 12 weeks ]

14.  Secondary:   Percentage of Participants With CDI Recurrence in Those With Compromised Immunity   [ Time Frame: 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


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01513239     History of Changes
Other Study ID Numbers: 3415A-002
132231 ( Registry Identifier: JAPIC-CTI )
2011-004994-94 ( EudraCT Number )
First Submitted: January 16, 2012
First Posted: January 20, 2012
Results First Submitted: October 24, 2016
Results First Posted: December 15, 2016
Last Update Posted: March 29, 2017