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| Sponsor: | CPL Associates |
|---|---|
| Collaborator: |
Sanofi-Aventis |
| Information provided by: | CPL Associates |
| ClinicalTrials.gov Identifier: | NCT00245453 |
Purpose
To measure the speed of bacterial eradication from the respiratory tract after administration of azithromycin or telithromycin.
| Condition | Intervention | Phase |
|---|---|---|
|
Pneumonia, Bacterial Bronchitis, Chronic |
Drug: azithromycin Drug: telithromycin Drug: Clarythromycin |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacokinetics/Dynamics Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Randomized Aseptic Pharmacokinetic Pharmacodynamic Outpatient Registry Trial of Respiratory Tract Infections in Adults (RAPPORT) |
| Enrollment: | 0 |
| Study Start Date: | October 2005 |
| Study Completion Date: | July 2006 |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: 1 Azithromycin |
Drug: azithromycin
250 mg tablets; 2 tablets on day 1 (500 mg load) and 1 tablet QD on days 2-5
|
| Active Comparator: 2 Clarythromycin |
Drug: Clarythromycin
500 mg extended release tablets; 2 tablets QD for 7 days
|
| Active Comparator: 3 Telithromycin |
Drug: telithromycin
400 mg tablets; 2 tablets once daily (QD) for 5 days
|
To Evaluate the relationship between rate of S. pneumoniae killing in sputum, PK/PD, and clinical response of oral telithromycin and azithromycin in patients with AECB or CAP and to determine if there is a difference in the rates of infection site bacterial killing (as described above) between these 3 antibiotics against penicillin- and erythromycin-resistant S.pneumoniae
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Others as per protocol
Contacts and Locations| United States, Kentucky | |
| Western Kentucky Pulmonary Clinic | |
| Louisville, Kentucky, United States, 42240 | |
| United States, Louisiana | |
| Northshore Research Associates | |
| Slidell, Louisiana, United States, 70461 | |
| Principal Investigator: | Jerome J Schentag, Pharm.D. | State University of New York at Buffalo |
| Study Director: | Joseph Paladino, Pharm.D. | State University of New York at Buffalo |
More Information
| ClinicalTrials.gov Identifier: | NCT00245453 History of Changes |
| Other Study ID Numbers: | HMR3647A6004 |
| Study First Received: | October 26, 2005 |
| Last Updated: | October 30, 2007 |
| Health Authority: | United States: Food and Drug Administration |
|
pneumonia Spneumoniae bronchitis telithromycin azithromycin |
|
Pneumonia, Bacterial Bronchitis Bronchitis, Chronic Pneumonia Respiratory Tract Infections Bacterial Infections Lung Diseases Respiratory Tract Diseases Bronchial Diseases Lung Diseases, Obstructive Pulmonary Disease, Chronic Obstructive |
Infection Azithromycin Clarithromycin Telithromycin Anti-Bacterial Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Protein Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |