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

NCT ID: NCT00237445

Last Updated: 2011-01-11

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 110 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-11-30
• Study Completion Date: 2006-09-30

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

Conditions

Pneumonia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

telithromycin

Intervention Type: DRUG

azithromycin

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sanofi

INDUSTRY

Sponsor Role: lead

Responsible Party

sanofi-aventis

Principal Investigators

Phyllis Diener

Role: STUDY_DIRECTOR

Sanofi

Locations

Sanofi-Aventis

Bridgewater, New Jersey, United States

Countries

United States

Other Identifiers

HMR3647A_4027

Identifier Type: -

Identifier Source: org_study_id