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

Phase 3

Completed

• Conditions: Intra-abdominal Infection

• Registration Number: NCT00481702
• Lead Sponsor: Merck Sharp & Dohme LLC

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2001-12
• Primary Completion: 2003-06
• Study Completion: 2003-06
• Study First Submitted: 2007-06-01
• Study First Submitted QC: 2007-06-01
• Study First Posted: 2007-06-04
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-17
• Last Update Posted: 2017-02-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

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

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Exclusion Criteria

• Patient has another infection, other than abdominal
• Female patient is pregnant or planning to become pregnant

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
That ertapenem is as effective as ceftriaxone/metronidazole in the treatment of an abdominal infection	2 weeks after treatment

Secondary Outcome Measures

Name	Time	Method
That ertapenem is as effective as ceftriaxone/metronidazole in the treatment of abdominal infection	4 weeks after treatment