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

Condition	Intervention	Phase
Pneumonia Ventilators, Mechanical	Drug: Doripenem	Phase III

Further Study Details: 

Primary Outcomes: Clinical response rate at the early follow-up visit.
Secondary Outcomes: 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..
Expected Total Enrollment:  400

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 consits 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.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

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

Please refer to this study by ClinicalTrials.gov identifier  NCT00211016

For more information please see the link below or email       info@veritasmedicine.com

Study chairs or principal investigators

Johnson & Johnson Pharmaceutical Research and Development, L.L.C. Clinical Trial,  Study Director,  Johnson & Johnson Pharmaceutical Research & Development, L.L.C.   

Study ID Numbers:  CR005386
Last Updated:  September 20, 2005
Record first received:  September 13, 2005
ClinicalTrials.gov Identifier:  NCT00211016
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-09-27