Doripenem in the Treatment of Hospital-Acquired Pneumonia
Primary Purpose
Pneumonia
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 Hospital-Acquired Pneumonia, Mechanical Ventilation
Eligibility 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
Sites / Locations
Outcomes
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.
Full Information
NCT ID
NCT00211003
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
NCT00211003
Brief Title
Doripenem in the Treatment of Hospital-Acquired Pneumonia
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2010
Overall Recruitment Status
Completed
Study Start Date
May 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 safety and effectiveness of doripenem in patients with hospital-acquired pneumonia (HAP).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pneumonia
Keywords
Hospital-Acquired Pneumonia, Mechanical Ventilation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
240 (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
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
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
PubMed Identifier
18549664
Citation
Rea-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.
Results Reference
derived
Links:
URL
http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_JNJ_6051&studyid=641&filename=CR005401_CSR.pdf
Description
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
Learn more about this trial
Doripenem in the Treatment of Hospital-Acquired Pneumonia
We'll reach out to this number within 24 hrs