Doripenem in the Treatment of Complicated Intra-Abdominal Infections

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

PHASE3

Total Enrollment

478 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-03-31

Study Completion Date

2006-01-31

Brief Summary

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The purpose of this study is to compare the clinical response rates of doripenem versus a comparator antibiotic in treatment of hospitalized patients with complicated intra-abdominal infections.

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Detailed Description

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Doripenem is an antibiotic medication not yet approved by the US FDA. This is a phase 3, multicenter, prospective, randomized, double-blind study of intravenous doripenem versus a comparator antibiotic to assess the effectiveness and safety of doripenem in the treatment of complicated intra-abdominal infections in hospitalized adults. The primary endpoint is the clinical response rate measured at late follow-up visit. The patients will receive either doripenem or comparator; treatment duration is 5 to 14 days.

Conditions

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Bacterial Infections and Mycoses Appendicitis Cholecystitis Pancreatitis Peritonitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Doripenem

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Has a requirement for surgical intervention within 24 hours of study entry
* Requirement of antibacterial therapy in addition to surgical intervention in certain intra-abdominal infections.

Exclusion Criteria

* Female patients who are pregnant, nursing, or if of child bearing potential not using a medically accepted, effective method of birth control
* Any rapidly-progressing disease or immediately life-threatening illness.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No