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

NCT00237445 | Terminated Phase 4

• 1 other identifier: HMR3647A_4027
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• To compare the effect of telithromycin versus azithromycin on clinical efficacy in CAP adult outpatients at the end of therapy

Interventions

telithromycin DRUG

azithromycin DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (1)

Sanofi-Aventis

Bridgewater, New Jersey, 08807, United States

Location

MeSH Terms

Conditions

Pneumonia

Interventions

telithromycin; Azithromycin

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Erythromycin; Macrolides; Polyketides; Lactones; Organic Chemicals

Study Officials

• Phyllis Diener

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 10, 2005
• First Posted: October 12, 2005
• Study Start: November 1, 2005
• Primary Completion: September 1, 2006
• Study Completion: September 1, 2006
• Last Updated: January 11, 2011

Record last verified: 2011-01

Locations

US (1)