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

Sanofi

Status and phase

Completed

Phase 4

Conditions

Pneumonia

Treatments

Drug: Telithromycin

Study type

Interventional

Funder types

Industry

Identifiers

NCT00538018

HMR3647A_4015

Details and patient eligibility

About

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.

Enrollment

978 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.