|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | Sanofi-Aventis |
|---|---|
| Information provided by: | Sanofi-Aventis |
| ClinicalTrials.gov Identifier: | NCT00237445 |
Purpose
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: | November 2005 |
| Study Completion Date: | September 2006 |
| Primary Completion Date: | September 2006 (Final data collection date for primary outcome measure) |
Eligibility| 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.
Contacts and Locations
More Information
| Responsible Party: | sanofi-aventis ( Study Director ) |
| Study ID Numbers: | HMR3647A/4027 |
| Study First Received: | October 10, 2005 |
| Last Updated: | December 8, 2009 |
| ClinicalTrials.gov Identifier: | NCT00237445 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Anti-Infective Agents Anti-Bacterial Agents Respiratory Tract Infections Respiratory Tract Diseases Therapeutic Uses |
Azithromycin Lung Diseases Pharmacologic Actions Telithromycin Pneumonia |