Pneumonia, Ventilators, Mechanical
Conditions
Keywords
Ventilator-Associated Pneumonia
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.
Interventions
DRUGdoripenem
Sponsors
Peninsula Pharmaceuticals, Inc.
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical response rate at the early follow-up visit. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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.. | — |
Outcome results
None listed