title: Cefixime vs. cefaclor in the treatment of acute otitis media in children: a randomized, comparative study.
abstract: The efficacy of cefixime was compared with that of cefaclor in the treatment of 63 patients with acute otitis media. Patients received either a single dose of cefixime (8 mg/kg/day) or 3 divided doses of cefaclor (40 mg/kg/day). On the basis of otoscopic and tympanometric results at 10 to 14 days after the start of treatment, 28 (97%) of 29 cefixime-treated patients and 25 (78%) of 32 cefaclor-treated patients had resolution of acute otitis media. The clinical cure rate associated with all organisms was 94% for cefixime (16 of 17 isolates) and 68% (13 of 19 isolates) for cefaclor. The cure rate for Streptococcus pneumoniae was 12 of 12 (100%) for cefixime and 7 of 7 (100%) for cefaclor; the cure rate for Haemophilus influenzae (which includes 2 patients with mixed infections) was 3 of 4 (75%) for cefixime and 2 of 7 (29%) for cefaclor. One clinical relapse occurred among 29 cefixime-treated patients; however, at 28 days 9 recurrences were observed. Three of 25 (9%) cefaclor-treated patients failed and 4 (13%) relapsed at 10 to 14 days, an additional 2 (10%) experienced recurrence by Day 28. Eight (28%) cefixime-treated patients experienced adverse events (7 gastrointestinal and 1 diarrhea and rash); 8 (25%) cefaclor-treated patients experienced adverse events (all gastrointestinal). Our data suggest that both at end of therapy and for 14 days thereafter, cefixime given once a day for acute otitis media is clinically equivalent to cefaclor given 3 times a day.
authors.affiliation: Children's National Medical Center, Washington, DC 20010.
authors.forename: W J
authors.initials: WJ
authors.lastname: Rodriguez
authors.forename: W
authors.initials: W
authors.lastname: Khan
authors.forename: T
authors.initials: T
authors.lastname: Sait
authors.forename: O P
authors.initials: OP
authors.lastname: Chhabra
authors.forename: T A
authors.initials: TA
authors.lastname: Bell
authors.forename: S
authors.initials: S
authors.lastname: Akram
authors.forename: V M
authors.initials: VM
authors.lastname: Kohlbrenner
mesh_terms: D000208:Acute Disease; D002433:Cefaclor / Q000627:therapeutic use*; D020682:Cefixime; D002439:Cefotaxime / Q000031:analogs & derivatives* / Q000627:therapeutic use; D002648:Child; D002675:Child, Preschool; D005260:Female; D006801:Humans; D007223:Infant; D008297:Male; D010034:Otitis Media with Effusion / Q000188:drug therapy* / Q000382:microbiology; D011446:Prospective Studies; D016037:Single-Blind Method
chemical_list: D002433:Cefaclor; D020682:Cefixime; D002439:Cefotaxime