Doripenem in the Treatment of Hospital-Acquired Pneumonia

This study has been completed.

First Received: September 13, 2005 Last Updated: March 24, 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:	NCT00211003

Purpose

The purpose of this study is to compare the safety and effectiveness of doripenem in patients with hospital-acquired pneumonia (HAP).

Condition	Intervention	Phase
Pneumonia	Drug: doripenem	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Multicenter, Randomized, Open-Label, Phase 3 Study to Compare the Safety and Effectiveness of Doripenem Versus a Comparator Antibiotic in Hospital-Acquired 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:

The clinical response rate 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 test results) monitored throughout the study.

Estimated Enrollment:	300
Study Start Date:	May 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, open-label (though with blinded outcome assessments), randomized study of doripenem versus a comparator antibiotic in patients with hospital-acquired pneumonia. The study consists of screening phase, open-label treatment phase, and follow-up. Both patients on ventilator and not on ventilator are enrolled. The primary endpoint is the clinical response rate at early follow-up visit.

The patients may receive either doripenem or comparator; total duration of the treatment is 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:

Patients hospitalized for >= 48 hours or those with prior hospital admission of at least 48 hours who were discharged within the last 48 hours

Exclusion Criteria:

Hospital-acquired pneumonia known at the time of enrollment to be caused by pathogen(s) resistant to certain antibiotics
Any rapidly progressing disease or immediately life-threatening illness

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00211003

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 Piperacillin/Tazobactam in Hospital-Acquired 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.

Réa-Neto A, Niederman M, Lobo SM, Schroeder E, Lee M, Kaniga K, Ketter N, Prokocimer P, Friedland I. Efficacy and safety of doripenem versus piperacillin/tazobactam in nosocomial pneumonia: a randomized, open-label, multicenter study. Curr Med Res Opin. 2008 Jul;24(7):2113-26. Epub 2008 Jun 11.

Study ID Numbers:	CR005401
Study First Received:	September 13, 2005
Last Updated:	March 24, 2008
ClinicalTrials.gov Identifier:	NCT00211003 History of Changes
Health Authority:	United States: Food and Drug Administration

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

Mechanical Ventilation
Hospital-Acquired Pneumonia

Study placed in the following topic categories:

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

Additional relevant MeSH terms:

Respiratory Tract Infections
Respiratory Tract Diseases
Lung Diseases
Pneumonia

ClinicalTrials.gov processed this record on September 02, 2009