Doripenem in the Treatment of Hospital-Acquired Pneumonia

This study has been completed.

Sponsor:

Collaborator:

Peninsula Pharmaceuticals, Inc.

Information provided by:

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

ClinicalTrials.gov Identifier:

NCT00211003

First received: September 13, 2005

Last updated: June 8, 2011

Last verified: April 2010

History of Changes

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 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
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: Health Facilities 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.


Enrollment:	240
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 & 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 ClinicalTrials.gov Identifier (NCT Number):

Kollef MH, Nathwani D, Merchant S, Gast C, Quintana A, Ketter N. Medical resource utilization among patients with ventilator-associated pneumonia: pooled analysis of randomized studies of doripenem versus comparators. Crit Care. 2010;14(3):R84. doi: 10.1186/cc9012. Epub 2010 May 10.

Kaniga K, Flamm R, Tong SY, Lee M, Friedland I, Redman R. Worldwide experience with the use of doripenem against extended-spectrum-beta-lactamase-producing and ciprofloxacin-resistant Enterobacteriaceae: analysis of six phase 3 clinical studies. Antimicrob Agents Chemother. 2010 May;54(5):2119-24. doi: 10.1128/AAC.01450-09. Epub 2010 Mar 8.

Zhanel GG, Ketter N, Rubinstein E, Friedland I, Redman R. Overview of seizure-inducing potential of doripenem. Drug Saf. 2009;32(9):709-16. doi: 10.2165/00002018-200932090-00001. Review.

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. doi: 10.1185/03007990802179255 . Epub 2008 Jun 11.


ClinicalTrials.gov Identifier:	NCT00211003 History of Changes
Other Study ID Numbers:	CR005401
Study First Received:	September 13, 2005
Last Updated:	June 8, 2011
Health Authority:	United States: Food and Drug Administration

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


Hospital-Acquired Pneumonia Mechanical Ventilation

Additional relevant MeSH terms:


Pneumonia Lung Diseases Respiratory Tract Diseases Respiratory Tract Infections

ClinicalTrials.gov processed this record on February 25, 2015

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