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Study to Demonstrate the Clinical Efficacy of Levofloxacin in the Treatment of Pneumonia

NCT00253955 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 460

Last updated 2008-11-10

No results posted yet for this study

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

Conditions

Interventions

DRUG

Levofloxacin

DRUG

Piperacillin/Tazobactam

Sponsors & Collaborators

Principal Investigators

  • Gilles Perdriset · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-06-30
Primary Completion
2007-05-31
Completion
2007-11-30

Countries

  • Austria
  • Belgium
  • Czechia
  • France
  • Germany
  • Greece
  • Guatemala
  • Italy
  • Lebanon
  • Mexico
  • Netherlands
  • Romania
  • Russia
  • South Africa
  • Spain
  • Turkey (Türkiye)
  • Venezuela

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00253955 on ClinicalTrials.gov