title: Cefixime compared with amoxicillin for treatment of acute otitis media.
abstract: Cefixime was compared with amoxicillin for treatment of acute otitis media in a randomized trial. Results of tympanocentesis on day 3 to 5 of therapy were used as the major outcome. Total daily doses were 8 mg/kg of cefixime and 40 mg/kg of amoxicillin. One hundred twenty-six patients were randomly assigned to receive treatment; 64 cultures grew pathogens. Pathogens were eradicated from the middle ear after 3 to 5 days of therapy in 27 (79.4%) of 34 children given amoxicillin and 26 (86.7%) of 30 children given cefixime (p = 0.47). When Streptococcus pneumoniae cases were analyzed, bacteriologic cure occurred in 14 (93.3%) of 15 children given amoxicillin and 12 (75%) of 16 given cefixime (p = 0.333). When cases of Haemophilus influenzae infection were analyzed, significantly more cures occurred with cefixime (10/10, 100%) than amoxicillin (8/13, 62%) (p = 0.046). Pathogens associated with failure of amoxicillin therapy were H. influenzae (five cases, two beta-lactamase-positive), S. pneumoniae (one case), and Moraxella catarrhalis (one case, beta-lactamase-positive). The four failures with cefixime therapy were all in patients infected with S. pneumoniae. Rates of rash, diarrhea, and vomiting were the same in both groups and did not necessitate stopping therapy. We conclude the following: (1) Cefixime and amoxicillin were equivalent in overall clinical and bacteriologic efficacy for otitis media. (2) Cefixime was more efficacious than amoxicillin in treating H. influenzae otitis media and should be preferred when H. influenzae is the suspected etiologic agent. (3) Side effects of both drugs were mild and equivalent.
authors.affiliation: Department of Pediatrics, Case Western Reserve School of Medicine, MetroHealth Medical Center, Cleveland, Ohio 44109.
authors.forename: C E
authors.initials: CE
authors.lastname: Johnson
authors.forename: S A
authors.initials: SA
authors.lastname: Carlin
authors.forename: D M
authors.initials: DM
authors.lastname: Super
authors.forename: J M
authors.initials: JM
authors.lastname: Rehmus
authors.forename: D G
authors.initials: DG
authors.lastname: Roberts
authors.forename: N C
authors.initials: NC
authors.lastname: Christopher
authors.forename: J K
authors.initials: JK
authors.lastname: Whitwell
authors.forename: P A
authors.initials: PA
authors.lastname: Shurin
mesh_terms: D000208:Acute Disease; D000293:Adolescent; D000658:Amoxicillin / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use*; D001424:Bacterial Infections / Q000188:drug therapy; D020682:Cefixime; D002439:Cefotaxime / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000494:pharmacology / Q000627:therapeutic use; D002648:Child; D002675:Child, Preschool; D004341:Drug Evaluation; D004352:Drug Resistance, Microbial; D005260:Female; D006193:Haemophilus influenzae / Q000187:drug effects / Q000302:isolation & purification; D006801:Humans; D007223:Infant; D008297:Male; D001936:Moraxella catarrhalis / Q000187:drug effects / Q000302:isolation & purification; D010033:Otitis Media / Q000188:drug therapy* / Q000382:microbiology; D013296:Streptococcus pneumoniae / Q000187:drug effects / Q000302:isolation & purification
chemical_list: D000658:Amoxicillin; D020682:Cefixime; D002439:Cefotaxime