Summary
This single-blind, randomised study compared clinical outcomes for patients aged 5 months to 5 years with otitis media who were treated with either clarithromycin (7.5 mg/kg twice daily) or cefuroxime axetil (10 to 15 mg/kg twice daily) for 7 days. Demographics were comparable for the two groups. Clinical success (clinical cure, clinical cure with effusion or improvement) was observed in 96% (66 of 69) of the clarithromycin group and 94% (63 of 67) of the cefuroxime axetil recipients. Recurrence occurred in 2 clarithromycin and 4 cefuroxime patients 4 weeks post-treatment. Eleven of 77 clarithromycin-treated and 11 of 75 cefuroxime axetil-treated patients experienced adverse events. Among these only 3 patients treated with clarithromycin (4%) and 5 patients treated with cefuroxime axetil (6%) discontinued use because of adverse events, none of which were serious. Clarithromycin suspension was well tolerated and highly effective in the treatment of otitis media in children, and was comparable with cefuroxime axetil when administered for 7 days.
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References
Bass JW, Cashman TM, Frostad AL, et al. Antimicrobials in the treatment of acute otitis media: a second clinical trial. Am J Dis Child 1973; 125: 397–403
Klein JO. State-of-the-art clinical articles. Otitis media. Clin Infect Dis 1994; 19(5): 823–32
Hardy DJ. Extent and spectrum of the antimicrobial activity of clarithromycin. Pediatr Infect Dis J 1993; 12: S99–S105
Kafetzis DA. Clarithromycin in the treatment of pediatric acute otitis media. Infect Med 1993; 10(S-C): 21–6
Sundberg L, Cederberg A. Penetration of clarithromycin and its 14-hydroxy metabolite into middle ear effusion in children with secretory otitis media. J Antimicrob Chemother 1994; 33: 299–307
Gan VN, Chu S-Y, Kusmiesz HT, et al. Pharmacokinetics of a clarithromycin suspension in infants and children. Antimicrob Agents Chemother 1992; 36(11): 2478–80
Aronovitz GH. Treatment of otitis media with cefuroxime axetil. S Med J 1988; 81(8): 978–80
Livermore DM, Anova M, Wu P, et al. Clavulanate and beta-lactamase induction. J Antimicrob Chemother 1989; 24 Suppl. B: 23–33
Moosdeen F, Keeble J, Williams JD. Induction/inhibition of chromosomal beta-lactamases by beta-lactamase inhibitors. Rev Infect Dis J 1986; 8 Suppl. 5: S562–S568
Pukander JS, Jero JP, Kaprio EA, et al. Clarithromycin vs. amoxicillin suspensions in the treatment of pediatric patients with acute otitis media. Ped Infect Dis J 1993; 12: S118–S121
McCarty JM, Phillips A, Wiisanen R. Comparative safety and efficacy of clarithromycin and amoxicillin/clavulanate in the treatment of acute otitis media in children. Ped Infect Dis J 1993; 12: S122–S127
Gooch WM III, Gan VN, Corder WT, et al. Clarithromycin and cefaclor suspensions in the treatment of acute otitis media in children. Ped Infect Dis J 1993; 12: S128–S133
Coles SJ, Addlestone MB, Kamdar MK, et al. A comparative study of clarithromycin and amoxycillin suspensions in the treatment of pediatric patients with acute otitis media. Infection 1993; 21:(4): 272–8
Feigin RD, Cherry JD. Otitis Media. Textbook of Pediatric Infectious Diseases. Vol. 1. 3rd ed. Philadelphia, PA: W.B. Saunders Co., 1992: 174–89
Luotonen J, Herva E, Karma P, et al. The bacteriology of acute otitis media in children with special reference to Streptococcus pneumoniae as studied by bacteriological and antigen detection methods. Scand J Infect Dis 1981; 113: 177–83
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Kafetzis, D.A., Malaka-Zafiriou, C., Bairamis, T. et al. Comparison of the Efficacy and Tolerability of Clarithromycin Suspension and Cefuroxime Axetil Suspension in the Treatment of Acute Otitis Media in Paediatric Patients. Clin. Drug Invest. 14, 192–199 (1997). https://doi.org/10.2165/00044011-199714030-00005
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DOI: https://doi.org/10.2165/00044011-199714030-00005