HOME HELP FEEDBACK SUBSCRIPTIONS ARCHIVE SEARCH TABLE OF CONTENTS		QUICK SEARCH:   [advanced] Author: Keyword(s): Year:  Vol:  Page:
Guest Access | Sign In via User Name/Password

This Article Full Text Free Full Text (PDF) Free Submit a response Alert me when this article is cited Alert me when eLetters are posted Alert me if a correction is posted Citation Map Services Email this article to a friend Similar articles in this journal Similar articles in ISI Web of Science Similar articles in PubMed Alert me to new issues of the journal Add to My Personal Article Archive Download to citation manager Citing Articles Citing Articles via HighWire Citing Articles via ISI Web of Science (14) Citing Articles via Google Scholar Google Scholar Articles by Drehobl, M. A. Articles by Breen, J. D. Search for Related Content PubMed PubMed Citation Articles by Drehobl, M. A. Articles by Breen, J. D.

Single-Dose Azithromycin Microspheres vs Clarithromycin Extended Release for the Treatment of Mild-to-Moderate Community-Acquired Pneumonia in Adults^*

^* From the Scripps Clinic-Clinical Research (Dr. Drehobl), San Diego, CA; Division Neumotisiologia (Dr. De Salvo), Hospital General de Agudos "Dr. E. Tornu," Buenos Aires, Argentina; and Pfizer Global Research and Development (Drs. Lewis and Breen), Pfizer Inc., New London, CT.

Correspondence to: Drew E. Lewis, MD, Pfizer Global Research and Development, 50 Pequot Ave, New London, CT 06320

Background: Community-acquired pneumonia (CAP) is a major cause of morbidity and mortality worldwide. The inability or failure of many subjects to adhere to standard antibiotic regimens, which may last up to 10 days, results in suboptimal antibiotic treatment. Treatment with a single-dose antibiotic regimen may improve compliance with prescribed therapy. A novel microsphere formulation of azithromycin provides a single-dose regimen while maintaining tolerability.

Study objective: To compare the efficacy and safety of a single 2.0-g dose of azithromycin microspheres to that of an extended-release formulation of clarithromycin (1.0 g/d for 7 days) for the treatment of adults with mild-to-moderate CAP.

Design: A phase III, multinational, multicenter, randomized, double-blind, double-dummy study, comparing single-dose azithromycin microspheres to extended-release clarithromycin, both administered orally.

Methods: Subjects with mild-to-moderate CAP (Fine class I and II) were included. The primary end point was clinical response at the test-of-cure (TOC) visit (days 14 to 21) in the clinical per protocol (CPP) population. The bacteriologic response at the TOC visit was assessed in subjects with a baseline pathogen.

Results: A total of 501 subjects were randomized, and 499 were treated. Clinical cure rates at the TOC visit in the CPP population were 92.6% (187 of 202 subjects) for azithromycin microspheres and 94.7% (198 of 209 subjects) for extended-release clarithromycin. Overall pathogen eradication rates were 91.8% (123 of 134 subjects) for azithromycin microspheres and 90.5% (153 of 169 subjects) for extended-release clarithromycin. Both agents were well tolerated. The incidence of treatment-related adverse events was 26.3% with azithromycin microspheres and 24.6% with extended-release clarithromycin. Most adverse events were mild to moderate in severity.

Conclusion: A single 2.0-g dose of azithromycin microspheres was as effective and well tolerated as a 7-day course of extended-release clarithromycin in the treatment of adults with mild-to-moderate CAP.

Key Words: azithromycin • clarithromycin • community-acquired pneumonia • single-dose regimen

This article has been cited by other articles:

				Single-Dose Treatment for Mild-to-Moderate CAP? Journal Watch Infectious Diseases, December 21, 2005; 2005(1221): 5 - 5. [Full Text]