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

Sponsor

Merck Sharp & Dohme LLC (Industry)

Overall Status

Completed

CT.gov ID

NCT00481702

Collaborator

(none)

300

Enrollment

Duration (Months)

Study Details

Study Description

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

Study Type:

Interventional

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 :

Dec 1, 2001

Actual Primary Completion Date :

Jun 1, 2003

Actual Study Completion Date :

Jun 1, 2003

Outcome Measures

Primary Outcome Measures

That ertapenem is as effective as ceftriaxone/metronidazole in the treatment of an abdominal infection [2 weeks after treatment]

Secondary Outcome Measures

That ertapenem is as effective as ceftriaxone/metronidazole in the treatment of abdominal infection [4 weeks after treatment]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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