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A Study to Evaluate the Safety and Effectiveness of Ertapenem Versus Ceftriaxone/Metronidazole in the Treatment of Intra-abdominal Infections in Adults (0826-802)

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: NCT00481702
Recruitment Status : Completed
First Posted : June 4, 2007
Last Update Posted : February 20, 2017
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme LLC

Study Description
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Brief Summary:
A multicenter study to evaluate the effectiveness of ertapenem compared to ceftriaxone/metronidazole in treating certain abdominal infections that require surgery in adult patients.

Condition or disease Intervention/treatment Phase
Intra-abdominal Infection Drug: Comparator: ceftriaxone sodium / Duration of Treatment: 8 Weeks Drug: MK0826, /Duration of Treatment : 8 Weeks Drug: Comparator: metronidazole / Duration of Treatment: 8 Weeks Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective, Multicenter, Open-Label, Randomized, Comparative Study to Evaluate the Efficacy, Safety, and Tolerability of Ertapenem Versus Ceftriaxone/Metronidazole in the Treatment of Intra-Abdominal Infections in Adults
Study Start Date : December 2001
Actual Primary Completion Date : June 2003
Actual Study Completion Date : June 2003

Resource links provided by the National Library of Medicine


Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. That ertapenem is as effective as ceftriaxone/metronidazole in the treatment of an abdominal infection [ Time Frame: 2 weeks after treatment ]

Secondary Outcome Measures :
  1. That ertapenem is as effective as ceftriaxone/metronidazole in the treatment of abdominal infection [ Time Frame: 4 weeks after treatment ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female patients age 18 or older
  • Patient has a diagnosis of intra-abdominal infection requiring surgery as evidenced by fever, elevated while blood cell count and abdominal pain

Exclusion Criteria:

  • Patient has another infection, other than abdominal
  • Female patient is pregnant or planning to become pregnant
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00481702


Sponsors and Collaborators
Merck Sharp & Dohme LLC
Investigators
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Study Director: Medical Monitor Merck Sharp & Dohme LLC
More Information
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Study Data/Documents: CSR Synopsis  This link exits the ClinicalTrials.gov site

Publications:

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Responsible Party: Merck Sharp & Dohme LLC
ClinicalTrials.gov Identifier: NCT00481702    
Other Study ID Numbers: 0826-802
2007_558
First Posted: June 4, 2007    Key Record Dates
Last Update Posted: February 20, 2017
Last Verified: February 2017
Additional relevant MeSH terms:
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Infections
Communicable Diseases
Intraabdominal Infections
Disease Attributes
Pathologic Processes
Metronidazole
 Ceftriaxone
Anti-Infective Agents
Anti-Bacterial Agents
Antiprotozoal Agents
Antiparasitic Agents