[Acute otitis media in children: a randomized and open clinical trial of the efficacy of 2 major antibiotics (erythromycin ethylsuccinate/acetyl sulfafurazole vs amoxicillin/clavulanic acid)]

Author(s): Begue P, Broussin B, Quinet B, Garabedian N, Sounthavong JP, Riviere F

Affiliation(s): Consultation de Pediatrie, Hopital Trousseau, Paris.

Publication date & source: 1990-02, Ann Pediatr (Paris)., 37(2):127-30.

Publication type: Clinical Trial; Randomized Controlled Trial

In a prospective randomized open study, 111 young children with otitis media were orally treated during 10 days with Pediazole (50 mg/kg/day in 3 divided doses) or amoxicillin + clavulanic acid (40 mg/kg/day in 3 or 4 divided doses) for efficacy and safety evaluation. 51 children wer assigned to amoxicillin + clavulanic acid (group I) and 60 to erythromycin-sulfisoxazole (group II). Mean age was respectively 24.7 months in group I and 23.4 months in group II. Results of efficacy evaluation were as follows: (table; see text) there was no statistically significant difference between the two treatment groups for efficacy. Overall safety was good. The treatment was discontinued only in four cases (3 in the amoxicillin + clavulanic acid group and 1 in the EES-sulfisoxazole group). In conclusion, Erythromycin sulfisoxazole combination (Pediazole) fits in with current epidemiological profile of Acute Otitis Media and represents a therapy of choice in this indication.