One dose ceftriaxone vs. ten days of amoxicillin clavulanate therapy for acute otitis media: clinical efficacy and change in nasopharyngeal flora

Objective. To compare the efficacy and the safety of a single intramuscular dose of ceftriaxone, 50 mg/kg, vs. a 10-day course of amoxicillin/clavulan ate (amox/clav) therapy, 80 mg/kg/day of amoxicillin: 10 mg/kg/day of clavu lanate in three divided doses, in children with acute otitis media (AOM) an d to evaluate the changes in nasopharyngeal flora after treatment. Methods. In a prospective, comparative, open randomized, multicenter trial, children were scheduled to return for visits on Days 12 to 14 (main end po int) and Days 28 to 42 after the beginning of treatment for AOM, A nasophar yngeal swab for bacterial culture was obtained before the treatment and at Days 12 to 14. Results. Between February, 1995, and May, 1996, 513 children with a mean ag e of 14.2 +/- 6.7 months were enrolled. All the patients were evaluable for the safety and intent-to-treat analyses and 463 for the per protocol effic acy. At Days 12 to 14 clinical success was obtained in 186 of the 235 child ren (79%) given ceftriaxone and in 188 of the 228 children (82.5%) treated with amox/clav. Among the patients with clinical success on Days 12 to 14, the success was maintained at Days 28 to 42 for 108 of 183 (59%) patients i n the ceftriaxone group and 103 of 187 (55%) patients in the amox/clav grou p. Before the antibiotic treatment the percentages of children carrying Str eptococcus pneumoniae (59.1%), Haemophilus influenzae (39.4%), Moraxella ca tarrhalis (55.7%) and the rate of penicillin-resistant S. pneumoniae (52.2% ) were comparable between the 2 groups. At Days 12 to 14 the carriage of S. pneumoniae and M. catarrhalis was significantly different between the pati ents treated with ceftriaxone, 43.9 and 42.2, respectively, and the patient s treated with amox/clav, 17.4 and 11.1%, respectively, Among the children carrying S. pneumoniae at Days 12 to 14, the percentage of penicillin-resis tant strains reached 63.4% in the ceftriaxone treatment group and 83.0% in the amox/clav treatment group, (P = 0.02). Adverse events (mainly diarrhea) related to the study medication were reported more frequently (P < 0.0001) in the amox/clav treatment group. Conclusions. In an area with a high rate of penicillin-resistant S. pneumon iae, a single dose of ceftriaxone is as efficient as a 10-day course of amo x/clav in the treatment of AOM in young children. There was for the two reg imens an increased rate of penicillin-resistant strains among the pneumococ ci carried, whereas the chance for a child to carry a penicillin resistant S. pneumoniae did not increase after treatment.