Doripenem in the Treatment of Ventilator-Associated Pneumonia
Phase 3
Completed
- Conditions
- PneumoniaVentilators, Mechanical
- Registration Number
- NCT00211016
- Brief Summary
The purpose of this study is to compare the clinical response rate of doripenem versus comparator in patients with ventilator-associated pneumonia (VAP).
- Detailed 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 318
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Clinical response rate at the early follow-up visit.
- Secondary Outcome Measures
Name Time Method 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..