A pilot study of single-dose azithromycin versus three-day azithromycin or single-dose ceftriaxone for uncomplicated acute otitis media in children☆

Abstract 

Background: The pharmacokinetic profile of azithromycin supports its use as single-dose therapy for uncomplicated acute otitis media (AOM) in children.

Objective: This study was designed to (1) compare the safety of single-dose oral azithromycin, 3 daily doses of oral azithromycin, and a single dose of intramuscular ceftriaxone for the treatment of uncomplicated AOM in children, and (2) provide preliminary efficacy data to support initiation of a larger, comparative trial of single-dose azithromycin for the treatment of uncomplicated AOM in children.

Methods: In this single-center pilot study, children with uncomplicated AOM were randomly assigned to receive single-dose oral azithromycin (30 mg/kg), 3-day oral azithromycin (10 mg/kg once daily), or single-dose intramuscular ceftriaxone (50 mg/kg). Tympanocentesis was performed before administration of the first dose, and clinical response was assessed on days 14–15 and 28–30.

Results: Between September 1995 and May 1997, 198 children (mean age, 2.5 years) were enrolled. All of the patients were evaluable for the safety and clinical intent-to-treat (ITT) analyses, and 98 were evaluable for the microbiologic ITT analysis. On day 14–15, rates of clinical success (cure or improvement) for the 3 treatment groups were: (97%) for single-dose azithromycin, (95%) for 3-day azithromycin, and (98%) for single-dose ceftriaxone. On day 28–30, the corresponding clinical success rates were 61/65 (94%), 61/66 (92%), and (97%). For the 98 microbiologically evaluable patients, clinical success rates at day 14–15 were (93%) for single-dose azithromycin, (89%) for 3-day azithromycin, and (100%) for single-dose ceftriaxone. On day 28–30, the corresponding clinical success rates were (90%), (86%), and (97%). Treatment-related adverse event rates for single-dose azithromycin, 3-day azithromycin, and single-dose ceftriaxone were 10.6%, 9.1%, and 9.1%, respectively.

Conclusion: In this pilot study comparing single-dose azithromycin, 3-day azithromycin, and single-dose ceftriaxone for the treatment of uncomplicated AOM in children, no differences were detected among the 3 regimens.

Keywords:  acute otitis media, azithromycin, ceftriaxone, Haemophilus influenzae, short-course therapy, Streptococcus pneumoniae

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