Doripenem in the Treatment of Complicated Intra-Abdominal Infections - Tabular View

Tracking Information

First Received Date ^ICMJE

September 13, 2005

Last Updated Date

March 28, 2008

Start Date ^ICMJE

March 2004

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Clinical response rate measured at late follow-up visit.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00210938 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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.

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Doripenem in the Treatment of Complicated Intra-Abdominal Infections

Official Title ^ICMJE

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 III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Pancreatitis
Appendicitis
Cholecystitis
Bacterial Infections and Mycoses
Peritonitis

Intervention ^ICMJE

Drug: Doripenem

Study Arms / Comparison Groups

Publications *

Zhanel GG, Ketter N, Rubinstein E, Friedland I, Redman R. Overview of seizure-inducing potential of doripenem. Drug Saf. 2009;32(9):709-16.

* 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 ^ICMJE

Completed

Estimated Enrollment ^ICMJE

346

Completion Date

January 2006

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Administrative Information

NCT ID ^ICMJE

NCT00210938

Responsible Party

Study ID Numbers ^ICMJE

CR005383

Study Sponsor ^ICMJE

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

Collaborators ^ICMJE

Peninsula Pharmaceuticals, Inc.

Investigators ^ICMJE

Study Director:

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

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

Information Provided By

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

Verification Date

March 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP