title: [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)].
abstract: 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.
authors.affiliation: Consultation de Pédiatrie, Hôpital Trousseau, Paris.
authors.forename: P
authors.initials: P
authors.lastname: Bégué
authors.forename: B
authors.initials: B
authors.lastname: Broussin
authors.forename: B
authors.initials: B
authors.lastname: Quinet
authors.forename: N
authors.initials: N
authors.lastname: Garabedian
authors.forename: J P
authors.initials: JP
authors.lastname: Sounthavong
authors.forename: F
authors.initials: F
authors.lastname: Rivière
mesh_terms: D000208:Acute Disease; D000658:Amoxicillin / Q000627:therapeutic use*; D019980:Amoxicillin-Potassium Clavulanate Combination; D000890:Anti-Infective Agents / Q000627:therapeutic use*; D002675:Child, Preschool; D002969:Clavulanic Acids / Q000627:therapeutic use*; D004338:Drug Combinations / Q000627:therapeutic use; D004359:Drug Therapy, Combination / Q000627:therapeutic use; D004361:Drug Tolerance; D004917:Erythromycin / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D007223:Infant; D008297:Male; D010033:Otitis Media / Q000188:drug therapy*; D011446:Prospective Studies; D016032:Randomized Controlled Trials as Topic; D012008:Recurrence; D013444:Sulfisoxazole / Q000627:therapeutic use*
chemical_list: D000890:Anti-Infective Agents; D002969:Clavulanic Acids; D004338:Drug Combinations; D004917:Erythromycin; D013444:Sulfisoxazole; D019980:Amoxicillin-Potassium Clavulanate Combination; D000658:Amoxicillin; C041478:MK 0641
vernacular_title: Otites moyennes aiguës de l'enfant: étude clinique randomisée et ouverte de l'efficacité de deux antibiotiques majeurs (ethylsuccinate d'erythromycine/acétyl-sulfafurazole versus amoxicillin/acid clavulanique)]