Doripenem in the Treatment of Ventilator-Associated Pneumonia

Phase 3 Completed 318 enrolled Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Peninsula Pharmaceuticals, Inc. · collab

RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to compare the clinical response rate of doripenem versus comparator in patients with ventilator-associated pneumonia (VAP).

Timeline

Start: 2004-08
Primary completion: —
Completion: 2006-10

Outcome

Met primary endpoint

paper which also showed that doripenem was clinically noninferior to comparators. PMID 20459721 ↗

Publications

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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Doripenem	Small molecule	500 mg	—