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
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.
