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Sponsored by: |
Sanofi-Aventis |
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Information provided by: | Sanofi-Aventis |
ClinicalTrials.gov Identifier: | NCT00237445 |
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
Condition | Intervention | Phase |
---|---|---|
Pneumonia |
Drug: telithromycin Drug: azithromycin |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Dose Comparison, Parallel Assignment |
Official Title: | 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 Ketek® Telithromycin Once Daily for 7 Days, or Zithromax® Azithromycin Once Daily for 5 Days |
Enrollment: | 110 |
Study Start Date: | September 2005 |
Study Completion Date: | September 2006 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Male or female outpatients aged 20 or greater.
Subjects with diagnosis of acute mild to moderate CAP based on at least one of the following:
new and sudden onset (equal or less than 48 hours) of at least two of the following signs or symptoms:
Exclusion Criteria:
Subjects presenting with any of the following will not be included in the study.
known bronchial obstruction or a history of postobstructive pneumonia.
chronic corticosteroid therapy.
Responsible Party: | sanofi-aventis ( Study Director ) |
Study ID Numbers: | HMR3647A/4027 |
Study First Received: | October 10, 2005 |
Last Updated: | April 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00237445 |
Health Authority: | United States: Food and Drug Administration |
Respiratory Tract Infections Respiratory Tract Diseases Azithromycin |
Lung Diseases Telithromycin Pneumonia |
Anti-Infective Agents Anti-Bacterial Agents Therapeutic Uses Pharmacologic Actions |