title: [Prevention of acute otitis media. Amoxicillin versus glycoproteins from Klebsiella pneumoniae. Study in children under 5 years of age].
abstract: Several studies in the English language literature have shown that continuous antibiotic prophylaxis is more effective than a placebo in preventing recurrent otitis media. In this prospective, randomized trial the effectiveness of continuous amoxicillin therapy was compared with that of glycoproteins from Klebsiella pneumoniae (GKP). The two treatments were administered during 3 months to children aged 1 to 5 years, who had at least 3 episodes of otitis media within the 3 months preceding their admission to the trial. The trial lasted from February 1989 to July 1990. It involved 60 children (mean age: 22.6 months) who had been seen as out-patients and had recovered from their latest episode of otitis. Thirty-three children received amoxicillin 25 mg/kg/day divided into two doses, during 3 months. Twenty-seven children were given GKP 2 tablets per day during 8 days in the 1st month and 1 tablets per day during 8 days in the following 2 months. During the study period, 14 cases of otitis media were observed in children under amoxicillin, as against 22 cases in children under GKP. When the type of day-nursery was taken into account as adjustment factor, the results showed a significantly lower percentage of failures in the amoxicillin group (P less than 0.03). Both treatments were well tolerated (no child was excluded from the trial for intolerance). No Clostridium difficile toxin developed in the amoxicillin group.
authors.affiliation: Association clinique et thérapeutique infantile du Val-de-Marne (ACTIV), Hôpital Intercommunal de Créteil.
authors.forename: R
authors.initials: R
authors.lastname: Cohen
authors.forename: F
authors.initials: F
authors.lastname: de la Rocque
authors.forename: M
authors.initials: M
authors.lastname: Boucherat
authors.forename: A
authors.initials: A
authors.lastname: Bouhanna
authors.forename: M D
authors.initials: MD
authors.lastname: Lecompte
authors.forename: A
authors.initials: A
authors.lastname: Brami
authors.forename: F
authors.initials: F
authors.lastname: Richoux
authors.forename: P
authors.initials: P
authors.lastname: Bedbeder
authors.forename: A
authors.initials: A
authors.lastname: Wollner
authors.forename: A
authors.initials: A
authors.lastname: Elbez
mesh_terms: D000208:Acute Disease; D000658:Amoxicillin / Q000627:therapeutic use*; D002177:Candidiasis / Q000188:drug therapy; D002675:Child, Preschool; D004756:Enterobacteriaceae Infections / Q000188:drug therapy; D005260:Female; D005500:Follow-Up Studies; D006023:Glycoproteins / Q000302:isolation & purification / Q000627:therapeutic use*; D006801:Humans; D007223:Infant; D007711:Klebsiella pneumoniae / Q000378:metabolism*; D008297:Male; D010033:Otitis Media / Q000382:microbiology / Q000517:prevention & control*; D012008:Recurrence; D013203:Staphylococcal Infections / Q000188:drug therapy; D013997:Time Factors
chemical_list: D006023:Glycoproteins; D000658:Amoxicillin
vernacular_title: Prévention des otites moyennes aiguës. Amoxicilline versus glycoprotéines de Klebsiella pneumoniae. Etude chez l'enfant de moins de 5 ans.