Doripenem in the Treatment of Ventilator-Associated Pneumonia - Full Text View

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

MedlinePlus related topics:

Pneumonia

ChemIDplus related topics:

Doripenem

U.S. FDA Resources

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

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

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

Study ID Numbers:	CR005386
First Received:	September 13, 2005
Last Updated:	April 11, 2008
ClinicalTrials.gov Identifier:	NCT00211016
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:

Respiratory Tract Infections

Respiratory Tract Diseases

Lung Diseases

Pneumonia, Ventilator-Associated

Cross Infection

Pneumonia

Additional relevant MeSH terms:

Infection

ClinicalTrials.gov processed this record on October 03, 2008

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