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Sponsored by: |
Advanced Life Sciences, Inc. |
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Information provided by: | Advanced Life Sciences, Inc. |
ClinicalTrials.gov Identifier: | NCT00336505 |
The purpose of this study is to compare the efficacy of cethromycin to clarithromycin for the treatment of mild to moderate community-acquired pneumonia (CAP).
Condition | Intervention | Phase |
---|---|---|
Pneumonia |
Drug: Cethromycin Drug: Clarithromycin |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Double-Blinded, Randomized, Parallel Group, Multi-Center, Multi-National Comparative Study of the Safety and Efficacy of Cethromycin 300 mg QD to Clarithromycin (BIAXIN® Filmtab®) 250 mg BID for the Treatment of Community-Acquired Pneumonia in Adults |
Estimated Enrollment: | 500 |
Study Start Date: | December 2005 |
Estimated Study Completion Date: | December 2006 |
Lower respiratory tract infections remain one of the leading causes of death worldwide. Increasing rates of antibiotic resistance and newer, more pervasive pneumonia-causative pathogens contribute to this statistic. Currently available macrolide antibiotics for the treatment of community-acquired pneumonia are slowly losing effectiveness, resulting in the need to develop newer drugs to fight resistant infections. In this study, we compare the safety and efficacy of a common macrolide, clarithromycin, to a new ketolide, cethromycin.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Illinois | |
USA - Advanced Life Sciences | |
Woodridge, Illinois, United States, 60517 | |
CANADA - Advanced Life Sciences | |
Woodridge, Illinois, United States, 60517 | |
SOUTH AFRICA - Advanced Life Sciences | |
Woodridge, Illinois, United States, 60517 |
Study Director: | David A. Eiznhamer, PhD | Advanced Life Sciences |
Study ID Numbers: | CL05-001 |
Study First Received: | June 9, 2006 |
Last Updated: | September 25, 2007 |
ClinicalTrials.gov Identifier: | NCT00336505 |
Health Authority: | United States: Food and Drug Administration |
Pneumonia Respiratory Infection Infectious Advanced Life |
Sciences Lung Pulmonary Cethromycin Clarithromycin Biaxin |
Clarithromycin Cethromycin Respiratory Tract Infections |
Respiratory Tract Diseases Lung Diseases Pneumonia |
Anti-Infective Agents Anti-Bacterial Agents Protein Synthesis Inhibitors Molecular Mechanisms of Pharmacological Action |
Therapeutic Uses Enzyme Inhibitors Pharmacologic Actions |