Telithromycin, Treating Adult Outpatients With Mild to Moderate Community-acquired Pneumonia (CAP) in High Bacterial Resistance Areas

NCT ID: NCT00538018

Last Updated: 2012-02-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 978 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-01-31
• Study Completion Date: 2004-06-30

Brief Summary

Demonstrate efficacy of telithromycin over single-agent oral antibiotics usually prescribed by local guidelines ("usual care") for treating adult outpatients with mild to moderate community-acquired pneumonia (CAP) in high bacterial resistance areas.

Conditions

Pneumonia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Telithromycin

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Adult outpatients with mild to moderate CAP. Diagnosis of CAP was based on the presence of fever and/or hyperleucocytosis and the new and sudden onset of at least two clinical signs and symptoms of pneumonia (cough, dyspnea or tachypnea, chills, pleuritic chest pain, purulent sputum or change in sputum character, auscultatory findings). Clinical diagnosis of CAP had to be confirmed by chest X-ray findings (e.g. presence of presumably new infiltrate). Specimens for microbiological documentation had to be collected within 24 hours prior to enrollment.

Exclusion Criteria

• Subjects requiring parenteral antibiotic treatment.
• Subjects with severe CAP requiring hospitalization. The CAP was to be considered as severe in the presence of any of the following conditions:
• chest X-ray showing a multilobar consolidation (> 1 lobe)3 and/ or an increase in the size of the opacity by greater than or = to 50% within 48 hours of the current evaluation
• shock
• altered mental status (disorientation to person, place or time that is not known to be chronic, lethargy, stupor or coma)
• total peripheral white blood cell count < 4,000/mm3
• requirement for mechanical ventilation
• requirement for vasopressors
• acute renal failure

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sanofi

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Sciences & Operations

Role: STUDY_DIRECTOR

Sanofi

Other Identifiers

HMR3647A_4015

Identifier Type: -

Identifier Source: org_study_id