title: A randomized controlled trial of amoxicillin plus clavulanate compared with cefaclor for treatment of acute otitis media.
abstract: We performed a randomized controlled trial of amoxicillin plus clavulanate versus cefaclor for treatment of acute otitis media. Total daily doses given in three divided doses were 40 mg/kg amoxicillin plus 10 mg/kg clavulanate, and 40 mg/kg cefaclor. Pathogens were eradicated from the middle ear exudate after 3 to 6 days of therapy in 35 (97%) of 36 patients given amoxicillin-clavulanate compared with 24 (75%) of 32 given cefaclor (P = 0.028). When analysis was restricted to patients with positive urine or serum drug assays during therapy, pathogens were eliminated in 33 (97%) of 34 patients given amoxicillin-clavulanate compared with 21 (75%) of 28 given cefaclor (P = 0.026). Bacterial isolates associated with bacteriologic failure of cefaclor therapy were Streptococcus pneumoniae (two patients), beta-lactamase-negative Haemophilus influenzae (four), and beta-lactamase-positive Branhamella catarrhalis (two). The single failure with amoxicillin-clavulanate therapy was associated with non-beta-lactamase-producing H. influenzae isolated from the middle ear exudate. We conclude that cefaclor is less efficacious than amoxicillin-clavulanate for the treatment of acute otitis media.
mesh_terms: D000208:Acute Disease; D000658:Amoxicillin / Q000008:administration & dosage / Q000627:therapeutic use*; D002433:Cefaclor / Q000008:administration & dosage / Q000627:therapeutic use*; D002506:Cephalexin / Q000031:analogs & derivatives*; D002648:Child; D002675:Child, Preschool; D019818:Clavulanic Acid; D002969:Clavulanic Acids / Q000008:administration & dosage / Q000627:therapeutic use*; D002986:Clinical Trials as Topic; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D005260:Female; D006193:Haemophilus influenzae / Q000302:isolation & purification; D006801:Humans; D007223:Infant; D008297:Male; D009343:Neisseria / Q000302:isolation & purification; D010033:Otitis Media / Q000188:drug therapy*; D010034:Otitis Media with Effusion / Q000188:drug therapy / Q000382:microbiology; D011897:Random Allocation; D013296:Streptococcus pneumoniae / Q000302:isolation & purification
chemical_list: D002969:Clavulanic Acids; D019818:Clavulanic Acid; D002433:Cefaclor; D000658:Amoxicillin; D002506:Cephalexin