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
478
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