Doripenem in the Treatment of Ventilator-Associated Pneumonia

Status Completed

Clinical Trial Summary

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

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00211016
Study type	Interventional
Source	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Contact
Status	Completed
Phase	Phase 3
Start date	August 2004
Completion date	October 2006

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