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Sponsored by: |
Pfizer |
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Information provided by: | Pfizer |
ClinicalTrials.gov Identifier: | NCT00643227 |
The study was performed to confirm that a single, 2.0 g oral dose of azithromycin sustained release (SR) at least as effective as 7 days of clarithromycin extended release (ER), 1.0 g by mouth once daily, when used to treat adults with mild to moderate community acquired pneumonia (CAP), and that both treatments were safe.
Condition | Intervention | Phase |
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Pneumonia |
Drug: clarithromycin extended release (ER) Drug: azithromycin SR |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Multicenter, Randomized, Double-Blind, Double-Dummy Comparative Trial of Azithromycin SR Versus Clarithromycin Extended Release for the Treatment of Mild to Moderate Community-Acquired Pneumonia in Adults |
Enrollment: | 504 |
Study Start Date: | January 2003 |
Study Completion Date: | March 2004 |
Arms | Assigned Interventions |
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1: Experimental |
Drug: clarithromycin extended release (ER)
7 days of clarithromycin extended release (ER), 1.0 g by mouth once daily
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2: Experimental |
Drug: azithromycin SR
Single, 2.0 g oral dose of azithromycin sustained release (SR) by mouth once daily
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Ages Eligible for Study: | 16 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Outpatients with a diagnosis of pneumonia, as demonstrated by a productive cough and at least 2 of the following signs and symptoms:
rales and/or evidence of pulmonary consolidation; dyspnea or tachypnea; elevated body temperature; or elevated total peripheral white blood cell count (WBC >10,000/mm3) or greater than 15% immature neutrophils were included. Patients were to have a chest radiograph demonstrating evidence of a new infiltrate or consolidation, and a Modified Fine Risk score of ≤ 70 (Fine Class I and II).
Exclusion Criteria:
Patients who were treated with any systemic antibiotic of greater than 1 dose or 1 combination dose (such as cephalosporin and macrolide) within the previous 7 days, or the likelihood of receiving other systemic antibiotics during participation in the study; were hospitalized in the previous 14 days or had an infection acquired in the hospital, and who were residents of a long-term care facility were excluded.
Study Director: | Pfizer CT.gov Call Center | Pfizer |
Responsible Party: | Pfizer, Inc. ( Diretor, Clinical Trial Disclosure Group ) |
Study ID Numbers: | A0661075 |
Study First Received: | March 19, 2008 |
Last Updated: | March 19, 2008 |
ClinicalTrials.gov Identifier: | NCT00643227 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Anti-Bacterial Agents Clarithromycin Respiratory Tract Infections Respiratory Tract Diseases |
Azithromycin Lung Diseases Pneumonia |
Anti-Infective Agents Molecular Mechanisms of Pharmacological Action Enzyme Inhibitors Pharmacologic Actions Clarithromycin Anti-Bacterial Agents Protein Synthesis Inhibitors |
Respiratory Tract Diseases Respiratory Tract Infections Lung Diseases Azithromycin Therapeutic Uses Pneumonia |