drugset / Trial / NCT00253955
Study to Demonstrate the Clinical Efficacy of Levofloxacin in the Treatment of Pneumonia
RandomizedParallel-groupOpen-labelTreatment
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
Timeline
- Start
- 2003-06
- Primary completion
- 2007-05
- Completion
- 2007-11
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Levofloxacin | Small molecule | 750 mg | — |
| Comparator | Piperacillin | Small molecule | 4 g | — |
| Comparator | Tazobactam | Small molecule | 500 mg | — |