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Sanofi-Aventis wanted the study terminated.
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| Name | Class |
|---|---|
| Sanofi | INDUSTRY |
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The major objectives of this research are to see how much, and for how long, telithromycin and azithromycin get into the fluids and cells of the lung.
The primary objective of this descriptive study is to determine and compare the plasma, epithelial lining fluid (ELF), and alveolar macrophage (AM) concentrations following multiple oral doses of telithromycin and azithromycin in healthy, non-smoking adult subjects.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Telithromycin | Drug | 800 mg once a day for 5 days |
| |
| azithromycin | Drug | 500 mg on day 1, and then 250 mg once-daily on days 2 through 5 |
| |
| bronchoalveolar lavage | Procedure | One bronchoscopy with bronchoalveolar lavage with each drug administration |
| |
| Telithromycin | Drug | Telithromycin 800 mg once a day |
|
| Measure | Description | Time Frame |
|---|---|---|
| Plasma and intrapulmonary drug concentrations and pharmacokinetic parameters | 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| How long does the study antibiotics get into the fluids and cells of the lung. | 7 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Keith A. Rodvold, Pharm.D. | University of Illinois at Chicago | Principal Investigator |
| Mark H. Gotfried, M.D. | Pulmonary Associates, PA | Principal Investigator |
| Larry H. Danziger, Pharm.D. | University of Illinois at Chicago | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pulmonary Associates PA | Phoenix | Arizona | 85006 | United States |
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| ID | Term |
|---|---|
| C106791 | telithromycin |
| D017963 | Azithromycin |
| D018893 | Bronchoalveolar Lavage |
| D001999 | Bronchoscopy |
| ID | Term |
|---|---|
| D004917 | Erythromycin |
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |
| D009930 |
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| Organic Chemicals |
| D007507 | Therapeutic Irrigation |
| D008919 | Investigative Techniques |
| D003948 | Diagnostic Techniques, Respiratory System |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D004724 | Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
| D019060 | Minimally Invasive Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D013510 | Pulmonary Surgical Procedures |
| D019616 | Thoracic Surgical Procedures |