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