Doripenem in the Treatment of Complicated Intra-Abdominal Infections

Sponsor

Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (Industry)

Overall Status

Completed

CT.gov ID

NCT00210938

Collaborator

Peninsula Pharmaceuticals, Inc. (Industry)

478

Enrollment

Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Bacterial Infections and Mycoses Appendicitis Cholecystitis Pancreatitis Peritonitis	Drug: Doripenem	Phase 3

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 Design

Study Type:

Interventional

Actual Enrollment :

478 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Mar 1, 2004

Actual Study Completion Date :

Jan 1, 2006

Outcome Measures

Primary Outcome Measures

Clinical response rate measured at late follow-up visit. []

Secondary Outcome Measures

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. []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Peninsula Pharmaceuticals, Inc.

Investigators

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