Azithromycin extended release vs amoxicillin/clavulanate: symptom resolution in acute sinusitis.
OBJECTIVE
The aim of the study was to compare early symptom resolution with a single 2-g dose of azithromycin extended release or 10 days of amoxicillin/clavulanate 875 mg/125 mg every 12 hours in patients with acute sinusitis.


METHODS
This was a prospective, randomized, open-label, observational study to mimic "real-world" conditions, including patients with symptoms of acute bacterial sinusitis lasting between 7 and 30 days. Key symptoms were assessed twice daily by patient diary, and patients were interviewed by telephone at 12 and 28 days. The primary end point was symptom resolution at 5 days, defined as reporting "no problem" with at least 3 of 4 diary symptoms in 2 consecutive measures in the per-protocol population. Secondary end points included additional antibiotic use, sinusitis-related quality of life, and treatment satisfaction.


RESULTS
Three hundred seventy-eight patients were randomized to a single dose of azithromycin extended release and 371 to 10 days of amoxicillin/clavulanate. In the per-protocol population at day 5, 70/236 patients (29.7%) in the azithromycin extended release arm and 45/238 patients (18.9%) in the amoxicillin/clavulanate arm had resolution of symptoms (difference = 10.8%; 95% confidence interval [CI], 3.1-18.4%). By day 28, 26/236 patients (11.0%) in the azithromycin extended release arm and 27/238 patients (11.3%) in the amoxicillin/clavulanate arm had used additional antibiotics (difference = -0.4%; 95% CI: -6.1% to 5.3%). Additional physician visits, quality of life, and overall satisfaction were similar between groups.


CONCLUSIONS
More patients randomized to azithromycin extended release experienced symptom resolution at day 5 than those randomized to amoxicillin/clavulanate, without experiencing differences in second antibiotic use at 28 days.
Marple
Bradley F
BF
Department of Otolaryngology-Head and Neck Surgery, University of Texas Southwestern Medical Center, Dallas, TX 75390, USA. bradley.marple@utsouthwestern.edu
Roberts
Craig S
CS
Frytak
Jennifer R
JR
Schabert
Vernon F
VF
Wegner
Jessica C
JC
Bhattacharyya
Helen
H
Piccirillo
Jay F
JF
Sanchez
Sonia P
SP
D000328:Adult; D019980:Amoxicillin-Potassium Clavulanate Combination / Q000008:administration & dosage*; D000900:Anti-Bacterial Agents / Q000008:administration & dosage*; D017963:Azithromycin / Q000008:administration & dosage*; D015331:Cohort Studies; D003692:Delayed-Action Preparations; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D008297:Male; D015523:Maxillary Sinusitis / Q000150:complications* / Q000188:drug therapy* / Q000382:microbiology; D008875:Middle Aged; D017060:Patient Satisfaction; D016896:Treatment Outcome
D000900:Anti-Bacterial Agents; D003692:Delayed-Action Preparations; D019980:Amoxicillin-Potassium Clavulanate Combination; D017963:Azithromycin