ELSEVIER IN7ERN*rION*LIOURNALOF zyxwvut Antimicrobial Agents International Journal of Antimicrobial Agents 6 (1996) 233-238 Comparative trial of 3-day azithromycin versus 1 O-day amoxycillinklavulanate potassium in the treatment of children with otitis media with effusion Adrian0 Arguedasa,b,*, Cecilia Loaizaa,b,c, Marcos Herreraa,b,c,, Edgar MohPb*” zyxwvutsrqponm “National Children’s Hospital, f?O. Box 1654-1000, San Josk Costa Rica bUniversidad Autbnoma de Ciencias Mgdkas, San Jo&, Costa Rica “Universidad de Costa Rica, San Jo&, Costa Rica Accepted 24 November 1995 acute zyxwvuts Abstract A randomized, open clinical trial was performed to compare azithromycin and amoxycillin/clavulanate potassium in children with acute otitis media with effusion. Patients were allocated to therapy with azithromycin (10 mg/kg once daily for 3 days) or amoxycillinlclavulanate potassium (40 mg/kg/day divided into three equal doses for 10 days). Clinical examination and tympano- metric evaluation were performed at baseline, and at day 3 to 5, day 10 to 14, day 28 to 30 and day 55 to 60 after the initiation of therapy. Tympanocentesis fluid cultures were collected at enrolment, and urine and blood samples were obtained at baseline and at day 10 to 11. Of 100 patients enrolled, 92 were considered evaluable. Middle ear cultures were positive in 53.2% of the patients; the most common pathogens w#:re Streptococcuspneumoniae (33%) and Haemophilus infuenzae (33%). The response was satisfactory in 47 (100%) patients treated with azithromycin and 42 (95.4%) patients receiving A/C. Rates of persistence of middle ear effusion were comparable. Nausea and loose stools were more common in children treated with amoxycillinlclavulanate potassium (P 5 0.02). Based on the comparable efficacy noted in this study, the lower incidence of side-effects and the convenience of a shorter duration of treatment, azithromycin represents an attractive therapeutic alternative to amoxycillin/clavulanate potassium and should be further evaluated in larger-scale clinical trials including patients with penicillin-resistant organisms. Keywords: Azithromycin; Acute otitis media; Amoxicillin/clavulanate; Tympanocentesis 1. Introduction Acute otitis media (AOM) is one of the most common infectious diseases of childhood [l-3]. Bacterial patho- gens are isolated from mid.dle ear fluid in about two- thirds of patients; S. pnetlmoniae, zyxwvutsrqponmlkjihgfedcbaZYXWVUTSRQPONMLKJIHGFEDCBA H. influenzae and M. catarrhalis are the most. common organisms identi- fied [4,5]. The selection of an antibiotic for the treatment of a AOM should be based on the antimicrobial spectrum, pharmacokinetic properties, safety and overall cost of *Corresponding author. Tel. (+50(i) 257 6686; Fax (+506) 257 6686. treatment [6,7]. The increased prevalence of B-lacta- mase-producing strains of H. influenzae (15% to 40%) and of M. catarrhalis (5% to 20%) [8,9] and, more re- cently, of S. pneumoniae relatively resistant (14%) or highly resistant (14% to 46%) to penicillin [lo,1 l] as the pathogens responsible for otitis media has raised concern about the efficacy of traditional antimicrobial agents. The established therapy for patients with AOM has been an oral antibiotic given for 10 days and often three or four times each day [ 1,6,7]; however, problems with drug compliance, especially after symptomatic improvement occurs, and drug-related side-effects have been noted. Azithromycin is a new 15-membered-ring macrolide antimicrobial agent, of the azalide subclass, with in vitro activity against common paediatric middle ear patho- gens [12-141. In an animal model, the 50% effective dose 0924-8579/96/$32.00 0 1996 Elsevier Science B.V. All rights reserved SSDI 0924- 8579(95)00066- t!