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| Sponsored by: |
Advanced Life Sciences, Inc. |
|---|---|
| Information provided by: | Advanced Life Sciences, Inc. |
| ClinicalTrials.gov Identifier: | NCT00336505 |
Purpose
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
other systemic antibiotic therapy, rifampin or rifabutin
Contacts and Locations| 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 |
More Information
| Study ID Numbers: | CL05-001 |
| Study First Received: | June 9, 2006 |
| Last Updated: | September 25, 2007 |
| ClinicalTrials.gov Identifier: | NCT00336505 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Pneumonia Respiratory Infection Infectious Advanced Life |
Sciences Lung Pulmonary Cethromycin Clarithromycin Biaxin |
|
Anti-Bacterial Agents Clarithromycin Cethromycin Respiratory Tract Infections |
Respiratory Tract Diseases Lung Diseases Pneumonia |
|
Anti-Infective Agents Molecular Mechanisms of Pharmacological Action Enzyme Inhibitors Pharmacologic Actions Clarithromycin Protein Synthesis Inhibitors Anti-Bacterial Agents |
Respiratory Tract Diseases Respiratory Tract Infections Cethromycin Lung Diseases Therapeutic Uses Pneumonia |