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

Merck Sharp & Dohme LLC300 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

300

Conditions

Intra-abdominal Infection

Interventions

Comparator: ceftriaxone sodium / Duration of Treatment: 8 WeeksDRUG

MK0826, /Duration of Treatment : 8 WeeksDRUG

Comparator: metronidazole / Duration of Treatment: 8 WeeksDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

That ertapenem is as effective as ceftriaxone/metronidazole in the treatment of an abdominal infection

Time frame: 2 weeks after treatment

Secondary Outcomes

That ertapenem is as effective as ceftriaxone/metronidazole in the treatment of abdominal infection

Time frame: 4 weeks after treatment

Data from ClinicalTrials.gov

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