Comparison of cefuroxime axetil, cefaclor, and amoxicillin-clavulanate potassium suspensions in acute otitis media in infants and children.
In this randomized, blinded, multicenter comparison study, 377 infants and children with acute otitis media (AOM) received a 10-day course of an oral suspension of one of the following: cefuroxime axetil (CAE), 30 mg/kg/day; cefaclor (CEC), 40 mg/kg/day; or amoxicillin-clavulanate potassium (AMX-CL), 40 mg/kg/day. Clinical efficacy was determined by pneumatic otoscopy and tympanometric testing 3 to 5, 11 to 14, and 22 to 26 days after the initiation of therapy. There was a statistically significant difference among the three treatment groups with respect to clinical outcome; more patients in the CAE group (62%) than in the CEC group (46%) or the AMX-CL group (52%) had complete resolution of signs and symptoms of AOM (including effusion). Paired comparisons revealed a significant difference in efficacy between CAE and CEC and a nearly significant difference between AMX-CL and CEC. Taste acceptability was highest for CEC and lowest for this formulation of CAE. Significantly more patients in the AMX-CL group than in the CAE or CEC group had a side effect, primarily diarrhea, vomiting, or diaper rash. We conclude that CAE suspension has greater clinical efficacy than CEC and fewer side effects than AMX-CL.
Pichichero
M
M
Department of Pediatrics, University of Rochester, NY 14642.
Aronovitz
G H
GH
Gooch
W M
WM
McLinn
S E
SE
Maddern
B
B
Johnson
C
C
Darden
P M
PM
D000158:Acoustic Impedance Tests; D000208:Acute Disease; D000284:Administration, Oral; D000658:Amoxicillin / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D019980:Amoxicillin-Potassium Clavulanate Combination; D000704:Analysis of Variance; D002433:Cefaclor / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D002444:Cefuroxime / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D002648:Child; D002675:Child, Preschool; D002969:Clavulanic Acids / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D005069:Evaluation Studies as Topic; D005260:Female; D006801:Humans; D007223:Infant; D008297:Male; D010033:Otitis Media / Q000188:drug therapy* / Q000503:physiopathology; D013997:Time Factors
D002969:Clavulanic Acids; D002433:Cefaclor; D019980:Amoxicillin-Potassium Clavulanate Combination; D000658:Amoxicillin; D002444:Cefuroxime; C040738:cefuroxime axetil