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Sponsored by: |
Sanofi-Aventis |
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Information provided by: | Sanofi-Aventis |
ClinicalTrials.gov Identifier: | NCT00132938 |
Primary Objective:
Secondary Objectives:
The secondary objectives of the study are:
Condition | Intervention | Phase |
---|---|---|
Chronic Bronchitis |
Drug: telithromycin |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | An Open-Label, Randomized, Multicenter, Clinical Study to Compare the Effects of Telithromycin, Azithromycin and Cefuroxime Axetil on the Penicillin or Macrolide Resistance of Streptococcus Pneumoniae in Patients With Acute Exacerbation of Chronic Bronchitis |
Estimated Enrollment: | 5660 |
Study Start Date: | January 2004 |
Ages Eligible for Study: | 35 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients meeting all of the following criteria will be considered for enrollment into the study:
Exclusion Criteria:
Patients presenting with any of the following will not be included in the study:
United States, New Jersey | |
Sanofi-Aventis | |
Bridgewater, New Jersey, United States | |
Belgium | |
Sanofi-Aventis | |
Brussels, Belgium | |
France | |
Sanofi-Aventis | |
Paris, France | |
Hungary | |
Sanofi-Aventis | |
Budapest, Hungary | |
Morocco | |
Sanofi-Aventis | |
Casablanca, Morocco | |
Spain | |
Sanofi-Aventis | |
Barcelona, Spain | |
Tunisia | |
Sanofi-Aventis | |
Megrine, Tunisia | |
Turkey | |
Sanofi-Aventis | |
Istanbul, Turkey |
Study Director: | Gilles Perdriset, MD | Sanofi-Aventis |
Study ID Numbers: | HMR3647A/4020, EudraCT # :2004-001412-30 |
Study First Received: | August 18, 2005 |
Last Updated: | October 4, 2007 |
ClinicalTrials.gov Identifier: | NCT00132938 |
Health Authority: | United States: Institutional Review Board |
Acute Disease Telithromycin Bronchitis, Chronic Lung Diseases, Obstructive Cefuroxime Cefuroxime axetil Respiratory Tract Diseases |
Respiratory Tract Infections Lung Diseases Azithromycin Bronchitis Pneumonia Pulmonary Disease, Chronic Obstructive |
Anti-Infective Agents Anti-Bacterial Agents Disease Attributes Pathologic Processes |
Bronchial Diseases Therapeutic Uses Pharmacologic Actions |