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

NCT00253955 | Completed Phase 3

• 1 other identifier: HR355_3035
• Study Type: interventional
• Target: 460
• Locations: 17 countries
• Sites: 17

Brief 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

Pneumonia

Outcome Measures

Primary Outcomes (1)

• Clinical efficacy data:-Infection related signs and symptoms-Chest X-ray

  from the start to the end of the study

Secondary Outcomes (2)

• Safety data: Clinical adverse event reporting, including SAE reporting

  From the inform consent signed until the end of the study

• Bacteriological efficacy data:-Cultures and susceptibility testing

  from the start to the end of the study

Study Arms (2)

1

EXPERIMENTAL

Drug: Levofloxacin

2

ACTIVE COMPARATOR

Drug: Piperacillin/Tazobactam

Interventions

Levofloxacin DRUG

1

Piperacillin/Tazobactam DRUG

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects meeting all of the following criteria will be considered for enrollment into the study:
• General ward or ICU hospitalized subject.
• Subject with diagnosis of hospital-acquired pneumonia of presumed bacterial origin based upon:
• Infection developing after at least 72 hours following hospital admission and
• At least three of the four following signs:
• Fever, defined as body temperature (oral or tympanic temperature ≥ 38°C or rectal temperature ≥ 38.5°C)
• Purulent tracheal sputum production/secretion or change in sputum character
• Total peripheral white blood cell (WBC) count \> 12 G/L or \< 4.5 G/L or 15% immature neutrophils (bands), regardless of total peripheral WBC count
• Increased plasma or serum C reactive protein (CRP) level as shown by a level of at least twice the upper boundary of the hospital normal range and
• Chest X-ray findings (anterior posterior \[AP\] or posterior anterior \[PA\], if possible lateral view) in agreement with the clinical diagnosis of bacterial pneumonia, i.e. appearance of new, progressive pulmonary infiltrate(s) attributable to infectious etiology.
• Subjects are required to have specimens collected for microbiological documentation within 24 hours prior to enrolment. Specimens should include at least one invasive or noninvasive lower respiratory tract specimen for Gram stain, culture and susceptibility testing, and at least 2 venous blood samples for culture and susceptibility testing.

You may not qualify if:

• Subjects presenting with any of the following will not be included in the study:
• Related to the hospital-acquired pneumonia (HAP):
• Suspected viral or fungal pneumonia, or HAP strongly suspected to be caused by MRSA (methicillin-resistant Staphylococcus aureus) or organisms responsible for atypical pneumonia, such as Chlamydia pneumoniae, Legionella pneumophila or Mycoplasma pneumoniae
• Patients with severe HAP, defined as presence of at least one of the following:
• In previously non-ventilated patients: need for mechanical ventilation consequently to HAP
• In previously ventilated patients: oxygenation rate defined by partial pressure of oxygen in arterial blood (PaO2)/fraction of inspired oxygen (FiO2) \< 200
• Radiographic findings compatible with severe HAP, i.e. showing either:
• Rapid progression (e.g. increase in the size of the opacity by ≥ 50% within 48 hours of the current evaluation)
• OR multilobar pneumonia (\> 2 lobes) or involvement of both lungs
• OR cavitation of a lung infiltrate
• Evidence of severe sepsis with hypotension and/or end-organ dysfunction, i.e.:
• Shock commonly evidenced by: systolic blood pressure \< 90 mmHg or diastolic blood pressure \< 60 mmHg
• In absence of previous vasopressors use, vasopressors use (except for fluid replacement) for more than 4 hours
• In presence of vasopressors use, increase in vasopressors use (except for fluid replacement) for more than 4 hours
• OR marked reduction in urine output (unless another explanation is available), i.e. in 1 hour: \< 20 mL or in 4 hours: \< 80 mL

Sponsors & Collaborators

• Sanofi: lead

Study Sites (17)

Sanofi-Aventis

Vienna, Austria

Location

Sanofi-Aventis

Brussels, Belgium

Location

Sanofi-Aventis

Prague, Czechia

Location

Sanofi-Aventis

Paris, France

Location

Sanofi-Aventis

Berlin, Germany

Location

Sanofi-Aventis

Athens, Greece

Location

Sanofi-Aventis

Guatemala City, Guatemala

Location

Sanofi-Aventis

Milan, Italy

Location

Sanofi-Aventis

Beirut, Lebanon

Location

Sanofi-Aventis

México, Mexico

Location

Sanofi-Aventis

Gouda, Netherlands

Location

Sanofi-Aventis

Bucharest, Romania

Location

Sanofi-Aventis

Moscow, Russia

Location

Sanofi-Aventis

Johannesburg, South Africa

Location

Sanofi-Aventis

Barcelona, Spain

Location

Sanofi-Aventis

Istanbul, Turkey (Türkiye)

Location

Sanofi-Aventis

Caracas, Venezuela

Location

MeSH Terms

Conditions

Pneumonia

Interventions

Levofloxacin; Piperacillin, Tazobactam Drug Combination

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Ofloxacin; Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Tazobactam; Penicillanic Acid; Penicillins; beta-Lactams; Lactams; Amides; Organic Chemicals; Piperacillin; Ampicillin; Penicillin G; Sulfur Compounds; Sulfones; Drug Combinations; Pharmaceutical Preparations

Study Officials

• Gilles Perdriset

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 14, 2005
• First Posted: November 15, 2005
• Study Start: June 1, 2003
• Primary Completion: May 1, 2007
• Study Completion: November 1, 2007
• Last Updated: November 10, 2008

Record last verified: 2008-11

Locations

ME (1); RU (1); BE (1); DE (1); GU (1); FR (1); AU (1); GR (1); IT (1); LE (1); NL (1); RO (1); CZ (1); ZA (1); ES (1); TU (1); VE (1)