The purpose of this study is to compare the safety and effectiveness of doripenem in patients with hospital-acquired pneumonia (HAP).

Condition	Intervention	Phase
Pneumonia	Drug: Doripenem	Phase III

Further Study Details: 

Primary Outcomes: Clinical response rate at the early follow-up visit.
Secondary Outcomes: The clinical response rate at early follow-up visit. Microbiological response rate at both early and late follow-up visits. Safety assessment (adverse events, changes in vital signs, laboratory test results) monitored throughout the study.
Expected Total Enrollment:  300

Doripenem is an antibiotic medication not yet approved by the US FDA. This is a phase 3, multicenter, prospective, open-label (though with blinded outcome assessments), randomized study of doripenem versus a comparator antibiotic in patients with hospital-acquired pneumonia. The study consists of screening phase, open-label treatment phase, and follow-up. Both patients on ventilator and not on ventilator are enrolled. The primary endpoint is the clinical response rate at early follow-up visit.

The patients may receive either doripenem or comparator; total duration of the treatment is 7 to 14 days.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria: - Patients hospitalized for >= 48 hours or those with prior hospital admission of at least 48 hours who were discharged within the last 48 hours.

Exclusion Criteria: - Hospital-acquired pneumonia known at the time of enrollment to be caused by pathogen(s) resistant to certain antibiotics - Any rapidly progressing disease or immediately life-threatening illness

Please refer to this study by ClinicalTrials.gov identifier  NCT00211003

For more information please see the link below or email       info@veritasmedicine.com

Study chairs or principal investigators

Johnson & Johnson Pharmaceutical Research and Development, L.L.C. Clinical Trial,  Study Director,  Johnson & Johnson Pharmaceutical Research & Development, L.L.C.   

Study ID Numbers:  CR005401
Last Updated:  September 20, 2005
Record first received:  September 13, 2005
ClinicalTrials.gov Identifier:  NCT00211003
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-09-27