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Sponsored by: |
Sanofi-Aventis |
---|---|
Information provided by: | Sanofi-Aventis |
ClinicalTrials.gov Identifier: | NCT00253955 |
Primary Objective:
Secondary Objectives:
The secondary objectives of the study are:
Condition | Intervention | Phase |
---|---|---|
Pneumonia |
Drug: Levofloxacin Drug: Piperacillin/Tazobactam |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
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) |
Enrollment: | 460 |
Study Start Date: | June 2003 |
Study Completion Date: | November 2007 |
Primary Completion Date: | May 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental | Drug: Levofloxacin |
2: Active Comparator | Drug: Piperacillin/Tazobactam |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Subjects meeting all of the following criteria will be considered for enrollment into the study:
Subject with diagnosis of hospital-acquired pneumonia of presumed bacterial origin based upon:
At least three of the four following signs:
Exclusion Criteria:
Subjects presenting with any of the following will not be included in the study:
Related to the hospital-acquired pneumonia (HAP):
Patients with severe HAP, defined as presence of at least one of the following:
Radiographic findings compatible with severe HAP, i.e. showing either:
Evidence of severe sepsis with hypotension and/or end-organ dysfunction, i.e.:
Related to medical history/concomitant conditions:
Immuno-compromised patients, such as those presenting with either:
Related to study drugs:
General:
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Study Director: | Gilles Perdriset | Sanofi-Aventis |
Responsible Party: | sanofi-aventis ( Medical Affairs Study Director ) |
Study ID Numbers: | HR355_3035 |
Study First Received: | November 14, 2005 |
Last Updated: | November 7, 2008 |
ClinicalTrials.gov Identifier: | NCT00253955 |
Health Authority: | Austria: Federal Ministry for Health and Women |
Penicillanic Acid Respiratory Tract Infections Respiratory Tract Diseases Lung Diseases Ofloxacin |
Tazobactam Piperacillin Piperacillin-tazobactam combination product Pneumonia |
Anti-Infective Agents Anti-Bacterial Agents Molecular Mechanisms of Pharmacological Action Therapeutic Uses Anti-Infective Agents, Urinary |
Enzyme Inhibitors Renal Agents Nucleic Acid Synthesis Inhibitors Pharmacologic Actions |