title: Comparative trial of 3 days of azithromycin versus 10 days of clarithromycin in the treatment of children with acute otitis media with effusion.
abstract: The authors compared the efficacy, safety and tolerance of azithromycin and clarithromycin in pediatric patients with acute otitis media. A randomized, open clinical trial was performed comparing azithromycin and clarithromycin in children aged 6 months to 12 years of age with acute otitis media with effusion. Patients were allocated to azithromycin at 10 mg/kg once daily for 3 days or to clarithromycin at 15 mg/kg day divided into two equal doses for 10 days. Clinical examinations and tympanometric evaluations were performed at baseline, day 3-5, day 10-14, day 28-30 and day 50-60. Tympanocentesis fluid cultures were collected at enrollment and urine and blood samples were obtained at baseline and day 10-14. Of 100 patients enrolled, 97 were considered evaluable. The most common middle ear pathogens were Streptococcus pneumoniae (60%), Haemophilus influenzae (15%) and Staphylococcus aureus (13%). Fifty patients (100%) treated with azithromycin and 45 (95.7%) patients treated with clarithromycin had a satisfactory clinical response. Rates of persistence of middle ear effusion and possible drug related side effects were comparable. Based on the efficacy and safety results, azithromycin for 3 days and clarithromycin for 10 days are considered to represent an attractive alternative for the treatment of children with acute otitis media.
authors.affiliation: National Children's Hospital, San Jose, Costa Rica. adriano@sol.racsa.co.cr
authors.forename: A
authors.initials: A
authors.lastname: Arguedas
authors.forename: C
authors.initials: C
authors.lastname: Loaiza
authors.forename: F
authors.initials: F
authors.lastname: Rodriguez
authors.forename: M L
authors.initials: ML
authors.lastname: Herrera
authors.forename: E
authors.initials: E
authors.lastname: Mohs
mesh_terms: D000900:Anti-Bacterial Agents / Q000009:adverse effects / Q000627:therapeutic use*; D001431:Bacteriological Techniques; D002648:Child; D002675:Child, Preschool; D017291:Clarithromycin / Q000009:adverse effects / Q000627:therapeutic use*; D004334:Drug Administration Schedule; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007223:Infant; D008297:Male; D010034:Otitis Media with Effusion / Q000188:drug therapy*; D010349:Patient Compliance; D016896:Treatment Outcome
chemical_list: D000900:Anti-Bacterial Agents; D017291:Clarithromycin