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A Study to Evaluate Ertapenem Versus It's Comparator in the Treatment of Complicated Intra-abdominal Infections in Adults (0826-050)(COMPLETED)

NCT ID: NCT00157898

Last Updated: 2017-02-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

134 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-01-31

Study Completion Date

2004-09-30

Brief Summary

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This was a prospective, randomized, controlled, open, and multi-center trial conducted to compare the clinical efficacy and safety of ertapenem with it's comparator before or following adequate surgical management of complicated intra-abdominal infection.

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Detailed Description

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Conditions

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Complicated Intra-abdominal Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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MK0826; ertapenem sodium

Intervention Type DRUG

Comparator: ceftriaxone + metronidazole

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Males or females between the ages of 18 and 75 who have complicated intra-abdominal infection.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Monitor

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Study Documents

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Document Type: CSR Synopsis

View Document

Other Identifiers

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MK0826-050

Identifier Type: -

Identifier Source: secondary_id

2005_068

Identifier Type: -

Identifier Source: secondary_id

0826-050

Identifier Type: -

Identifier Source: org_study_id

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