Doripenem in the Treatment of Ventilator-Associated Pneumonia

This study has been completed.

First Received: September 13, 2005 Last Updated: April 11, 2008 History of Changes

Sponsors and Collaborators:	Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Peninsula Pharmaceuticals, Inc.
Information provided by:	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier:	NCT00211016

Purpose

The purpose of this study is to compare the clinical response rate of doripenem versus comparator in patients with ventilator-associated pneumonia (VAP).

Condition	Intervention	Phase
Ventilators, Mechanical Pneumonia	Drug: doripenem	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Safety Study
Official Title:	A Multicenter, Randomized, Open-Label, Phase 3 Study of Doripenem Versus a Comparator Antibiotic in the Treatment of Ventilator-Associated Pneumonia

Resource links provided by NLM:

MedlinePlus related topics: Pneumonia

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 at the early follow-up visit.

Secondary Outcome Measures:

Clinical response rate at the late follow-up visit. Microbiological response at both early and late follow-up visits. Safety assessment (adverse events, vital signs, laboratory test results) conducted throughout the study..

Estimated Enrollment:	400
Study Start Date:	August 2004
Study Completion Date:	October 2006

Detailed Description:

Doripenem is an antibiotic medication not yet approved by the US FDA. This is a phase 3, multicenter, prospective, randomized, open-label study of doripenem versus comparator to assess the effectiveness and safety of doripenem in the treatment of VAP in adult patients. The study consits of screening phase, open-label treatment phase, and follow-up. The treatment duration is from 7 to 14 days. The primary endpoint is the clinical response rate of doripenem at the early follow-up visit.

The patients will receive either doripenem or comparator for 7 to 14 days.

Eligibility

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

Criteria

Inclusion Criteria:

Patient has received mechanical ventilation for > 24 hours
Presence of a new or progressive infiltrate on chest x-ray

Exclusion Criteria:

Believed at study entry to have ventilator-associated pneumonia caused solely by pathogen(s) resistant to certain antibiotics
History of moderate or severe hypersensitivity reactions to certain antibiotics

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00211016

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, Randomized, Open-Label, Phase 3 Study to Compare the Safety and Efficacy of Intravenous Doripenem with that of Intravenous Imipenem in Ventilator-Associated Pneumonia 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:	CR005386
Study First Received:	September 13, 2005
Last Updated:	April 11, 2008
ClinicalTrials.gov Identifier:	NCT00211016 History of Changes
Health Authority:	United States: Food and Drug Administration

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

Ventilator-Associated Pneumonia

Study placed in the following topic categories:

Anti-Bacterial Agents
Respiratory Tract Infections
Respiratory Tract Diseases
Lung Diseases

Pneumonia, Ventilator-Associated
Cross Infection
Pneumonia

Additional relevant MeSH terms:

Respiratory Tract Infections
Respiratory Tract Diseases
Lung Diseases
Infection

Pneumonia, Ventilator-Associated
Cross Infection
Pneumonia

ClinicalTrials.gov processed this record on September 02, 2009