Study to Demonstrate the Clinical Efficacy of Levofloxacin in the Treatment of Pneumonia
Status:
Completed
Trial end date:
2007-11-01
Target enrollment:
Participant gender:
Summary
Primary Objective:
- The primary objective of the study is to demonstrate the non-inferiority in clinical
efficacy at the test of cure (TOC) visit planned 5-7 days after treatment completion of
levofloxacin 750 mg once daily (od) in comparison with piperacillin/tazobactam 4 g/500
mg every 8 hours in treating adult patients suffering from mild to moderate
hospital-acquired pneumonia.
Secondary Objectives:
The secondary objectives of the study are:
- To assess the bacteriological efficacy at the test of cure (TOC) visit
- To assess the clinical and bacteriological efficacy at the end of study (EOS) visit, 28
to 32 days after treatment ends
- To assess the tolerability of both drugs
Phase:
Phase 3
Details
Lead Sponsor:
Sanofi
Treatments:
Levofloxacin Ofloxacin Penicillanic Acid Piperacillin Piperacillin, Tazobactam Drug Combination Tazobactam