Doripenem in the Treatment of Complicated Intra-Abdominal Infections

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 rates of doripenem versus a
      comparator antibiotic in 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 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.

Study Phase

Phase 3

Study Type

Interventional

Primary Outcome

Clinical response rate measured at late follow-up visit.

Secondary Outcome

 Clinical response rate measured at early follow-up visit. Microbiological response rate at both early and late follow-up visits. Safety assessment (adverse events, changes in vital signs, laboratory tests 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

Start Date

March 2004

Completion Date

January 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

NCT00210938

Organization ID

CR005383

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