Doripenem in the Treatment of Complicated Intra-Abdominal Infections

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Brief Title

Doripenem in the Treatment of Complicated Intra-Abdominal Infections

Official Title

A Multicenter, Double-Blind, Randomized, Phase 3 Study of Doripenem Versus Comparator Antibiotic in the Treatment of Complicated Intra-Abdominal Infections

Brief Summary

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

Detailed Description

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

Study Phase

Phase 3

Study Type

Interventional

Primary Outcome

The clinical response measured at late follow-up visit.

Secondary Outcome

 The clinical response at early follow-up visit. Microbiological response at both early and late follow-up visits. Safety assessment (adverse events, changes in vital signs, laboratory test results) conducted throughout the study.

Condition

Bacterial Infections and Mycoses

Intervention

doripenem

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Drug

Estimated Enrollment

483

Start Date

March 2004

Completion Date

March 2006

Eligibility Criteria

        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

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial, ,

Administrative Informations

NCT ID

NCT00229060

Organization ID

CR005389

Study Sponsor

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Collaborators

 Peninsula Pharmaceuticals, Inc.

Study Sponsor

Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial, Study Director, Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Verification Date

April 2010