study comparing the clinical efficacy and health outcomes of outpatients with mild to moderate community-acquired pneumonia (cap) treated with either telithromycin once daily for 7 days, or azithromycin once daily for 5 days

Conditions: Pneumonia

Summary: a multinational, multicenter, randomized, double-blind, study in areas of high pneumococcal resistance comparing the clinical efficacy and health outcomes of outpatients with mild to moderate community-acquired pneumonia (cap) treated with either telithromycin once daily for 7 days, or azithromycin once daily for 5 days


Eligibility criteria:
inclusion criteria: male or female outpatients aged 20 or greater. * subjects with a positive binax now s. pneumoniae urinary antigen test and/or positive gram stain for diplococci. * subjects with ≤ 7 days of signs and symptoms of cap. * subjects with chest x-ray findings that support a diagnosis of acute pneumonia with presence of a new infiltrate. for subjects with history of chronic obstructive pulmonary disease (copd), a comparison to previous chest x-ray report is required to confirm the finding of new infiltrates. subjects with diagnosis of acute mild to moderate cap based on at least one of the following: * fever (oral \>37.5°c/99.5°f or axillary \>37.4°c/99.4°f or rectal \>38.5°c/101.5°f) or * elevated total peripheral white blood cell count \>10,000/mm3 or \>15% immature neutrophils (bands), regardless of total peripheral white count and * new and sudden onset (equal or less than 48 hours) of at least two of the following signs or symptoms: * cough * dyspnea or tachypnea (particularly if progressive in nature) * pleuritic chest pain * purulent sputum production or change in sputum character * auscultatory findings (such as rales and/or evidence of pulmonary consolidation) exclusion criteria: * subjects presenting with any of the following will not be included in the study. * subjects with cap requiring hospitalization. * subjects with signs and symptoms of severe cap lasting greater than 7 days. * subjects requiring parenteral antibiotic treatment. * subjects discharged from hospital within the 10 days before study entry. * subjects with visible/gross aspiration pneumonia. * subjects with any concomitant pulmonary disease, condition or complication that could confound the interpretation or evaluation of drug efficacy or safety, including: * severe bronchiectasis, cystic fibrosis or suspected active pulmonary tuberculosis * suspected acute pulmonary embolism * emphysema, lung abscess, extra pulmonary extension (e.g., meningitis, septic arthritis, endocarditis) * known bronchial obstruction or a history of postobstructive pneumonia. * subjects with neoplastic lung disease (lung cancer) or another malignancy metastatic to the lungs, and/or requiring chemotherapeutic interventions for this or other neoplasms. * subjects with infection requiring administration of other systemic antimicrobial agents. * subjects with progressively fatal disease; life expectancy ≤3 months. * subjects with myasthenia gravis. * subjects with any concomitant condition, including severe and/or uncontrolled cardiovascular, neurologic, endocrine, or other severe and/or uncontrolled major systemic disease that make implementation of the protocol or interpretation of the study results difficult. * immunocompromised subjects, such as: * known hiv subjects with cd4+ t-lymphocyte count dated less than 3 months \<200/mm3 and /or hiv subjects treated with isoniazide or clarithromycin as prophylaxis * neutropenia (\<1500 neutrophils/mm3) not attributable to the acute infectious disease * metastatic or hematological malignancy * splenectomy or known hyposplenia or asplenia * chronic corticosteroid therapy. * subjects with a history of congenital or a family history of long qt syndrome (if not excluded by previous ecg) and subjects with known acquired qt interval prolongation * known severe impaired renal function as shown by creatinine clearance \< 30 ml/min either measured or estimated with cockroft formula. * subjects who have received more than 24 hours of effective treatment with other antibiotics, within the 7 days prior to enrollment in the study. * subjects with a known or suspected hypersensitivity to, or a known or suspected serious adverse reaction to telithromycin or any macrolide antibiotic. * subjects who will require on-study treatment with medications known to have potential drug interactions, including ergot alkaloids derivatives, terfenadine, astemizole, cisapride, pimozide, simvastatin, atorvastatin and lovastatin (see section 6.2). * subjects who have received any investigational drug within 1 month prior to study entry or such treatment is planned for during the study period. * subjects who are pregnant or breast-feeding. * subjects with recent drug or alcohol abuse.subjects with a mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study. * subject is the investigator or any subinvestigator, research assistance, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol. * subjects already enrolled in this study.