Objective. To compare the clinical efficacy of a 5-day cefdinir course with
a 10-day cefprozil course in the treatment of pediatric acute otitis media
(AOM).
Design. Comparative, investigator-blinded multicenter trial.
Setting: Primary care, ambulatory,
Patients. Children ages 6 months through 12 years with clinical symptoms an
d tympanic membrane signs of AOM, plus tympanometric-confirmed middle ear e
ffusion in at least 1 ear. Of the 435 patients enrolled in the study, 373 w
ere evaluable,
Intervention. Patients received cefdinir 14 mg/kg/day divided twice a day f
or 5 days or cefprozil 30 mg/kg/day divided twice a day for 10 days. Main o
utcome measures. Clinical resolution of tympanic membrane signs and symptom
s of AOM determined at end of therapy on Study Days 9 to 11,
Results. The clinical cure rate at end of therapy was 80% (152 of 190) for
cefdinir-treated patients and 82.5% (151 of 183) for cefprozil-treated pati
ents (95% confidence interval, 10.43% to 5.4%), Diarrhea and overall advers
e reactions, respectively, occurred in 7.8 and 13% of cefdinir-treated pati
ents and in 4.2 and 12% of cefprozil-treated patients.
Conclusions, A short course 5-day regimen of cefdinir was as clinically eff
ective and well-tolerated as a 10-day regimen of cefprozil in the treatment
of nonrefractory AOM.