Doripenem in the Treatment of Hospital-Acquired Pneumonia
A Multicenter, Randomized, Open-Label, Phase 3 Study to Compare the Safety and Effectiveness of Doripenem Versus a Comparator Antibiotic in Hospital-Acquired Pneumonia
1 other identifier
interventional
240
0 countries
N/A
Brief Summary
The purpose of this study is to compare the safety and effectiveness of doripenem in patients with hospital-acquired pneumonia (HAP).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started May 2004
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2004
CompletedFirst Submitted
Initial submission to the registry
September 13, 2005
CompletedFirst Posted
Study publicly available on registry
September 21, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2006
CompletedJune 10, 2011
April 1, 2010
September 13, 2005
June 8, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Clinical response rate at the early follow-up visit.
Secondary Outcomes (1)
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.
Interventions
Eligibility Criteria
You may qualify if:
- Patients hospitalized for \>= 48 hours or those with prior hospital admission of at least 48 hours who were discharged within the last 48 hours.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (4)
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.
PMID: 20459721DERIVEDKaniga 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.
PMID: 20211892DERIVEDZhanel 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.
PMID: 19670912DERIVEDRea-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.
PMID: 18549664DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 13, 2005
First Posted
September 21, 2005
Study Start
May 1, 2004
Study Completion
October 1, 2006
Last Updated
June 10, 2011
Record last verified: 2010-04