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| Sponsor: | Sanofi-Aventis |
|---|---|
| Information provided by: | Sanofi-Aventis |
| ClinicalTrials.gov Identifier: | NCT00132938 |
Purpose
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 |
Eligibility| 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:
Contacts and Locations| 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 |
More Information
| Study ID Numbers: | HMR3647A/4020, EudraCT # :2004-001412-30 |
| Study First Received: | August 18, 2005 |
| Last Updated: | October 4, 2007 |
| ClinicalTrials.gov Identifier: | NCT00132938 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
Acute Disease Anti-Infective Agents Disease Attributes Bronchial Diseases Pharmacologic Actions Telithromycin Bronchitis, Chronic Anti-Bacterial Agents |
Lung Diseases, Obstructive Pathologic Processes Respiratory Tract Diseases Respiratory Tract Infections Therapeutic Uses Lung Diseases Bronchitis Pulmonary Disease, Chronic Obstructive |