Doripenem in the Treatment of Complicated Intra-Abdominal Infections

This study has been completed.

First Received: September 13, 2005 Last Updated: March 28, 2008 History of Changes

Sponsor:	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Collaborator:	Peninsula Pharmaceuticals, Inc.
Information provided by:	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier:	NCT00210938

Purpose

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	Intervention	Phase
Pancreatitis Appendicitis Cholecystitis Bacterial Infections and Mycoses Peritonitis	Drug: Doripenem	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Multicenter, Double-Blind, Randomized, Phase 3 Study of Doripenem Versus Comparator Antibiotic in the Treatment of Complicated Intra-Abdominal Infections

Resource links provided by NLM:

MedlinePlus related topics: Antibiotics Appendicitis Bacterial Infections

Drug Information available for: Doripenem

U.S. FDA Resources

Further study details as provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:

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.

Estimated Enrollment:	346
Study Start Date:	March 2004
Study Completion Date:	January 2006

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00210938

Sponsors and Collaborators

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

Peninsula Pharmaceuticals, Inc.

Investigators

Study Director:

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

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

More Information

Additional Information:

A Multicenter, Double-Blind, Randomized, Phase 3 Study to Compare the Safety and Efficacy of Intravenous Doripenem with that of Meropenem in Complicated Intra-abdominal Infections This link exits the ClinicalTrials.gov site

This link exits the ClinicalTrials.gov site

No publications provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

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

Study ID Numbers:	CR005383
Study First Received:	September 13, 2005
Last Updated:	March 28, 2008
ClinicalTrials.gov Identifier:	NCT00210938 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:

Complicated Intra-Abdominal Infections
Cholecystitis
Peritonitis
Appendicitis

Additional relevant MeSH terms:

Gallbladder Diseases
Bacterial Infections
Communicable Diseases
Gastrointestinal Diseases
Peritonitis
Cholecystitis
Infection
Intestinal Diseases
Cecal Diseases

Digestive System Diseases
Acalculous Cholecystitis
Biliary Tract Diseases
Appendicitis
Peritoneal Diseases
Pancreatic Diseases
Gastroenteritis
Pancreatitis

ClinicalTrials.gov processed this record on November 25, 2009