Efficacy and Safety of Ertapenem Sodium (MK-0826) Following Colorectal Surgery in Chinese Adults (MK-0826-056)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01254344
First received: December 3, 2010
Last updated: October 16, 2012
Last verified: October 2012
Results First Received: October 16, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Conditions: Infection
Surgical Site Infection
Interventions: Drug: ertapenem sodium
Drug: ceftriaxone sodium
Drug: placebo to metronidazole
Drug: metronidazole

  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
No text entered.

Reporting Groups
  Description
Ertapenem Ertapenem sodium 1 g administered intravenously (IV) as a single dose followed by matching placebo to metronidazole administered IV as a single dose
Ceftriaxone/Metronidazole Ceftriaxone sodium 2 g administered intravenously (IV) as a single dose followed by metronidazole 500 mg administered IV as a single dose

Participant Flow:   Overall Study
    Ertapenem     Ceftriaxone/Metronidazole  
STARTED     299     300  
Treated     290     297  
COMPLETED     286     281  
NOT COMPLETED     13     19  
Adverse Event                 2                 5  
Physician Decision                 7                 4  
Protocol Violation                 1                 4  
Withdrawal by Subject                 3                 6  



  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
Ertapenem Ertapenem sodium 1 g administered intravenously (IV) as a single dose followed by matching placebo to metronidazole administered IV as a single dose
Ceftriaxone/Metronidazole Ceftriaxone sodium 2 g administered intravenously (IV) as a single dose followed by metronidazole 500 mg administered IV as a single dose
Total Total of all reporting groups

Baseline Measures
    Ertapenem     Ceftriaxone/Metronidazole     Total  
Number of Participants  
[units: participants]
  290     297     587  
Age  
[units: years]
Mean ± Standard Deviation
  59.4  ± 11.4     59.1  ± 12.1     59.2  ± 11.8  
Gender  
[units: participants]
     
Female     125     127     252  
Male     165     170     335  



  Outcome Measures
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1.  Primary:   Percentage of Participants With Success of Prophylaxis   [ Time Frame: From study drug dose (day of surgery) up to 4 weeks post therapy ]

2.  Secondary:   Percentage of Participants With Favorable Clinical Response   [ Time Frame: 4 weeks posttreatment ]


  Serious Adverse Events


  Other Adverse Events


  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.


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.  


Results Point of Contact:  
Name/Title: Naimi Missoum
Organization: Merck Sharp & Dohme (China) Ltd.
phone: +8621 2211 8546
e-mail: naimi_missoum@merck.com


No publications provided


Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01254344     History of Changes
Other Study ID Numbers: MK-0826-056
Study First Received: December 3, 2010
Results First Received: October 16, 2012
Last Updated: October 16, 2012
Health Authority: China: Food and Drug Administration