Clinical Question:
Is a single 2-gram dose of azithromycin more effective
than levofloxacin in the treatment of mild-to-moderate
community-acquired pneumonia?
Bottom Line:
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.
Reference:
Novel, single-dose microsphere formulation of
azithromycin versus 7-day levofloxacin therapy for
treatment of mild to moderate community-acquired
Pneumonia in adults.D'Ignazio J, Camere MA, Lewis DE,
Jorgensen D, Breen JD. Antimicrob Agents Chemother. 2005
Oct;49(10):4035-41
Study Design:
Randomized controlled trial (double-blinded)
Setting:
Outpatient
Synopsis:
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 |