title: Comparison of cefuroxime axetil and amoxicillin-clavulanate suspensions in treatment of acute otitis media with effusion in children.
abstract: Two hundred sixty-three pediatric patients from the ages of 3 months to 11 years were enrolled in a randomized, investigator-blinded, multicenter study comparing the clinical and bacteriological efficacies and safety of cefuroxime axetil suspension (CAE) with those of amoxicillin-clavulanate suspension (AMX-CL) in the treatment of acute otitis media with effusion. Patients received CAE at 30 mg/kg of body weight per day (n = 165) in two divided doses or AMX-CL at 40 mg/kg/day (n = 98) in three divided doses for 10 days. The primary pathogens among 200 isolates from pretreatment cultures of middle ear fluid were identified as follows: Haemophilus influenzae (39%), over a third of which were beta-lactamase positive; Streptococcus pneumoniae (34%); and Moraxella catarrhalis (16%). Pathogens were eradicated or presumed to be eradicated from 81% (95 of 118) and 76% (50 of 66) of bacteriologically evaluable patients in the CAE and AMX-CL groups, respectively. A satisfactory clinical response (cure or improvement with or without resolution of effusion) occurred in 113 (77%) of 146 clinically evaluable patients in the CAE group and in 66 (74%) of 89 evaluable patients in the AMX-CL group. Clinical failure or recurrence (within 2 weeks following the completion of treatment) occurred in 22 and 26% of CAE- and AMX-CL-treated patients, respectively. Drug-related adverse events occurred in 18% of CAE-treated patients, whereas they occurred in 39% of AMX-CL-treated patients (P < 0.001); diarrhea or loose stools was the most commonly reported adverse event (CAE, 12%; AMX-CL, 31%; P < 0.001). These results indicate that CAE given twice daily is as effective as AMX-CL given three times daily in the treatment of acute otitis media with effusion in pediatric patients, but CAE was associated with significantly fewer drug-related adverse events.
authors.affiliation: Scottsdale Pediatrics, Arizona 85260.
authors.forename: S E
authors.initials: SE
authors.lastname: McLinn
authors.forename: M
authors.initials: M
authors.lastname: Moskal
authors.forename: J
authors.initials: J
authors.lastname: Goldfarb
authors.forename: F
authors.initials: F
authors.lastname: Bodor
authors.forename: G
authors.initials: G
authors.lastname: Aronovitz
authors.forename: R
authors.initials: R
authors.lastname: Schwartz
authors.forename: P
authors.initials: P
authors.lastname: Self
authors.forename: M J
authors.initials: MJ
authors.lastname: Ossi
mesh_terms: D000658:Amoxicillin / Q000009:adverse effects / Q000627:therapeutic use; D019980:Amoxicillin-Potassium Clavulanate Combination; D002444:Cefuroxime / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D002648:Child; D002675:Child, Preschool; D002969:Clavulanic Acids / Q000009:adverse effects / Q000627:therapeutic use; D005260:Female; D006801:Humans; D007223:Infant; D008297:Male; D010034:Otitis Media with Effusion / Q000188:drug therapy*; D011355:Prodrugs / Q000009:adverse effects / Q000627:therapeutic use*; D013535:Suspensions
chemical_list: D002969:Clavulanic Acids; D011355:Prodrugs; D013535:Suspensions; D019980:Amoxicillin-Potassium Clavulanate Combination; D000658:Amoxicillin; D002444:Cefuroxime; C040738:cefuroxime axetil