Doripenem in the Treatment of Hospital-Acquired Pneumonia
Phase 3
Completed
- Conditions
- Pneumonia
- Registration Number
- NCT00211003
- Brief Summary
The purpose of this study is to compare the safety and effectiveness of doripenem in patients with hospital-acquired pneumonia (HAP).
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 240
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
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 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.