Pneumonia
Conditions
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.
Interventions
DRUGTelithromycin
Sponsors
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the effect of telithromycin versus usual care on the total symptoms score of pneumonia and on health outcomes, in CAP adult outpatients at the end of therapy visit. | (Days 8-11) |
Secondary
| Measure | Time frame |
|---|---|
| For health outcomes at the test of cure visit; e.g. additional LRTI-related antibiotic use, LRTI related hospitalization with length of stay and LRTI related office visit/emergency room visit. | (Days 17-21) |
Outcome results
None listed