Novel, Single-Dose Microsphere Formulation of Azithromycin versus 7-Day Levofloxacin Therapy for Treatment of Mild to Moderate Community-Acquired Pneumonia in Adults

Abstract

This randomized, double-blind, noninferiority study was designed to demonstrate that a single 2.0-g oral dose of a novel microsphere formulation of azithromycin was at least as effective as 7 days of levofloxacin, 500 mg/day, in the treatment of adult patients with mild to moderate community-acquired pneumonia (Fine classes I, II, and III). In total, 427 subjects were randomly assigned to receive either a single 2.0-g dose of azithromycin microspheres (n ‫؍‬ 213) or a 7-day regimen of levofloxacin (n ‫؍‬ 214). At baseline, 219 of 423 (51.8%) treated subjects had at least one pathogen identified by culture, PCR, or serology. The primary end point was the clinical response (cure or failure) in the "clinical per protocol" population at test of cure (days 13 to 24). Clinical cure rates were 89.7% (156 of 174) for azithromycin microspheres and 93.7% (177 of 189) for levofloxacin (treatment difference, ؊4.0%; 95% confidence interval, ؊9.7%, 1.7%). Bacteriologic success at test of cure in the "bacteriologic per protocol" population was 90.7% (97 of 107) for azithromycin microspheres and 92.3% (120 of 130) for levofloxacin (treatment difference, ؊1.7%; 95% confidence interval, ؊8.8%, 5.5%). Both treatment regimens were well tolerated; the incidence of treatment-related adverse events was 19.9% and 12.3% for azithromycin and levofloxacin, respectively. A single 2.0-g dose of azithromycin microspheres was at least as effective as a 7-day course of levofloxacin in the treatment of mild to moderate community-acquired pneumonia in adult outpatients.

Respiratory fluoroquinolones for the treatment of community-acquired pneumonia: a meta-analysis of randomized controlled trials

“…14,15,[19][20][21][26][27][28][31][32][33][34][35][36] Overall, treatment with fluoroquinolones was successful for 84.2% of patients. Treatment with comparator antibiotics was successful for 82.2% of patients.…”

“…Data about mortality in the intention-to-treat population were provided in 18 trials [14][15][16][17][18][19]21,22,24,26,27,[29][30][31][32][33][34]36 and ranged from 0% to 7% (mean 2.7%) in the fluoroquinolone groups and from 0.5% to 8% (mean 3.4%) in the comparator groups. Mortality rates were not different between the 2 groups of patients (Figure 2, OR 0.85, 95% CI 0.65-1.12).…”

“…Five trials included outpatients. 15,20,23,24,33 Both intravenous and oral administration were used depending on the severity of pneumonia and the ability of patients to receive medications orally.…”

“…[14][15][16][17][18]20,21,26,27,[29][30][31][32] Isolates recovered from all patients enrolled in the studies were tested for resistance against the study antibiotics and for penicillin resistance. Only one S. aureus isolate resistant to levofloxacin was found in these 13 studies.…”

A Case of Community-Acquired Pneumonia Due to <i>Legionella pneumophila</i> Serogroup 9 Wherein Initial Treatment with Single-Dose Oral Azithromycin Appeared Useful

“…Those results indicated that a single 2-g dose of oral azithromycin leads to higher concentrations in both serum and alveolar macrophages, the same as intravenous azithromycin, although the AUC0-24 in alveolar macrophages from a single 2-g dose of oral azithromycin was approximately half of that with intravenous administration, and the measured concentrations differed between subjects. Single 2-g doses of oral azithromycin are reportedly well tolerated and as effective as a 7-day course of levofloxacin in the treatment of mild to moderate CAP among adult outpatients (10). Although Legionella pneumonia was not evaluated in this study, a single 2-g dose of azithromycin could represent a useful treatment option for mild to moderate Legionella pneumonia as well as other pneumonias, because of the high concentrations indicated above.…”