Pneumonia Clinical Trial
Official title:
An Open-Label, Multicenter, Multinational, Centrally Randomized, Two-Arm Parallel-Group Study to Demonstrate the Non-Inferiority in Clinical Efficacy of Levofloxacin 750mg od in Comparison With Piperacillin/Tazobactam 4g/500mg Every 8 Hours in the Treatment of Mild to Moderate Hospital-Acquired Pneumonia Adult Patients in Both General Wards and ICU (Intensive Care Unit)
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
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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