[An open randomized trial, Pediazole versus cefaclor in the treatment of acute otitis media in children].

The combination of erythromycin ethylsuccinate and acetyl sulfafuroxazole (Pediazole = ES) is effective against Hemophilus influenzae, including beta-lactamase-producing strains, and against Streptococcus pneumoniae, including macrolide-resistant strains. In this study, mean daily dosage was 40-50 mg/kg for cefaclor and 50 mg/kg ES + 150 mg/kg sulfamide for Pediazole. Both products were given in three divided doses per day for ten days. Tolerance was evaluable in 106 children and effectiveness in 103 children including 52 in the ES group and 51 in the cefaclor group. Mean age was 23.5 months and both groups were comparable as concerns age, weight, previous ENT disease, and severity of the otitis media. Tolerance was satisfactory in both groups. Clinical results were as follows: failures before or at completion of the course, 5/52 in the ES group versus 13/51 in the cefaclor for the treatment of children with acute otitis media.