Pneumonia
Conditions
Brief 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
Interventions
DRUGtelithromycin
DRUGazithromycin
Sponsors
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluate clinical cure rates of telithromycin over azithromycin for treating adult outpatients with mild to moderate community-acquired pneumonia (CAP) in high pneumococcal bacterial resistance areas, at the test of cure visit (Days 17-21). | — |
Secondary
| Measure | Time frame |
|---|---|
| To compare the effect of telithromycin versus azithromycin on clinical efficacy in CAP adult outpatients at the end of therapy | — |
Countries
United States
Outcome results
None listed