Status:
COMPLETED
Doripenem in the Treatment of Ventilator-Associated Pneumonia
Lead Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Collaborating Sponsors:
Peninsula Pharmaceuticals, Inc.
Conditions:
Pneumonia
Ventilators, Mechanical
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 effectivene...
Eligibility Criteria
Inclusion
- Patient has received mechanical ventilation for \> 24 hours
- Presence of a new or progressive infiltrate on chest x-ray
Exclusion
- 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
Key Trial Info
Start Date :
August 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2006
Estimated Enrollment :
318 Patients enrolled
Trial Details
Trial ID
NCT00211016
Start Date
August 1 2004
End Date
October 1 2006
Last Update
June 10 2011
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