Efficacy of ceftibuten in 5 versus 10 days treatment of recurrent acute otitis media in children.

Objective: in recurrent acute otitis media (AOM) several alternative treatments are suggested, e.g. cephalosporins. Information about the optimal duration of treatment in recurrent AOM is sparse. The aim of the present study was to compare the efficacy of ceftibuten in 5 versus 10 days treatment in recurrent AOM in children.

Methods: this was a single-blind (doctor blinded), randomized, multicentre study with two parallel groups. Eleven investigators at six centres in the west of Sweden enrolled a total of 180 patients. Outpatients with a new clinical AOM within 1 month were randomized to 5 or 10 days treatment with ceftibuten, 9 mg/kg/day, as a single dose.

Results: the mean age of the patients was 1.2 years (range 6 months-8 years). The patients had on average had three antibiotic treatments during the preceding 12 months. The recurrence rates in the 5- and 10-day groups were 21.4 and 4.5%, respectively, at first follow-up visit day 12 (P=0.001). The total recurrence rates between the two groups during the whole follow-up period of 40 days, 35 and 30%, respectively, did not differ significantly. The rate of recurrence did not correlate to nasopharyngeal findings of Streptococcus pneumoniae or Haemophilus influenzae. Pneumococci with decreased susceptibility to penicillin were found in 5% of all pneumococci, and beta-lactamase producing H. influenzae in 8%. Adverse events were reported less frequently in the 5- compared with the 10-day treatment group.

Conclusion: this study on young children with recurrent otitis media has shown no statistical difference between ceftibuten given once daily for 5 and 10 days as determined on day 40. The 10-day treatment was significantly better at early follow-up.