Back to resultsDoripenem in the Treatment of Ventilator-Associated Pneumonia
Primary Purpose
Pneumonia, Ventilators, Mechanical
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
doripenem
Sponsored by
About this trial
This is an interventional treatment trial for Pneumonia focused on measuring Ventilator-Associated Pneumonia
Eligibility 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
Sites / Locations
Outcomes
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..
Full Information
NCT ID
NCT00211016
First Posted
September 13, 2005
Last Updated
June 8, 2011
Sponsor
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Collaborators
Peninsula Pharmaceuticals, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00211016
Brief Title
Doripenem in the Treatment of Ventilator-Associated Pneumonia
Official Title
A Multicenter, Randomized, Open-Label, Phase 3 Study of Doripenem Versus a Comparator Antibiotic in the Treatment of Ventilator-Associated Pneumonia
Study Type
Interventional
2. Study Status
Record Verification Date
March 2010
Overall Recruitment Status
Completed
Study Start Date
August 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Collaborators
Peninsula Pharmaceuticals, Inc.
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to compare the clinical response rate of doripenem versus comparator in patients with ventilator-associated pneumonia (VAP).
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 consists 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pneumonia, Ventilators, Mechanical
Keywords
Ventilator-Associated Pneumonia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
318 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
doripenem
Primary Outcome Measure Information:
Title
Clinical response rate at the early follow-up visit.
Secondary Outcome Measure Information:
Title
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..
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial
Organizational Affiliation
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Official's Role
Study Director
12. IPD Sharing Statement
Citations:
PubMed Identifier
20459721
Citation
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.
Results Reference
derived
PubMed Identifier
20211892
Citation
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.
Results Reference
derived
PubMed Identifier
19670912
Citation
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.
Results Reference
derived
Links:
URL
http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_JNJ_6051&studyid=638&filename=CR005386_CSR.pdf
Description
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
Learn more about this trial
Doripenem in the Treatment of Ventilator-Associated Pneumonia
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