Doripenem in the Treatment of Ventilator-Associated Pneumonia
Status and phase
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Details and patient eligibility
About
The purpose of this study is to compare the clinical response rate of doripenem versus comparator in patients with ventilator-associated pneumonia (VAP).
Full 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.
Enrollment
Sex
Ages
Volunteers
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
Trial design
Primary purpose
Allocation
Interventional model
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Data sourced from clinicaltrials.gov
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