Parent-reported outcomes for treatment of acute otitis media with cefdinir or amoxicillin/clavulanate oral suspensions.
OBJECTIVE
To compare parent-reported outcomes (satisfaction, tolerability, compliance, and work/daycare missed) for children (aged 6 months to 6 years) receiving either cefdinir or amoxicillin/clavulanate for acute otitis media.


METHODS
In a phase IV, investigator-blinded, parallel-group, randomized, multicenter study, parents or legal guardians were asked to complete the Otitis Parent Questionnaire (OPQ) 12-14 days after the first dose of cefdinir or amoxicillin/clavulanate oral suspensions. Responses in each of the outcome domains were analyzed using non-parametric statistical analysis.


RESULTS
Of 367 parents/guardians who completed the questionnaire, better ease of use (p = 0.009) and taste (p < 0.0001) were associated with cefdinir versus amoxicillin/clavulanate treatment, and children were significantly more likely to experience vomiting with amoxicillin/clavulanate (16% vs 8%; p = 0.016). Parents also reported that their children were much more likely to take all of their medication if receiving cefdinir (68% vs 53% for amoxicillin/clavulanate; p = 0.005). There were no statistically significant differences between groups in work/daycare missed.


CONCLUSIONS
Based on parents' assessment using the OPQ, cefdinir was easier to administer and tasted better than amoxicillin/clavulanate. Children who received cefdinir also experienced less vomiting and had greater compliance than children who received amoxicillin/clavulanate.
Cifaldi
Mary A
MA
Health Economics and Outcomes Research, Abbott Laboratories, Abbott Park, Illinois 60064-6124, USA. Mary.Cifaldi@abbott.com
Paris
Maria M
MM
Devcich
Karen J
KJ
Bukofzer
Stanley
S
D000284:Administration, Oral; D019980:Amoxicillin-Potassium Clavulanate Combination / Q000008:administration & dosage / Q000493:pharmacokinetics / Q000627:therapeutic use*; D000077525:Cefdinir; D002511:Cephalosporins / Q000008:administration & dosage / Q000493:pharmacokinetics / Q000627:therapeutic use*; D002648:Child; D002675:Child, Preschool; D017327:Clinical Trials, Phase IV as Topic; D004361:Drug Tolerance / Q000502:physiology; D005260:Female; D006801:Humans; D007223:Infant; D008297:Male; D010033:Otitis Media / Q000175:diagnosis / Q000188:drug therapy* / Q000382:microbiology; D010290:Parents; D010349:Patient Compliance / Q000706:statistics & numerical data; D017060:Patient Satisfaction / Q000706:statistics & numerical data; D016032:Randomized Controlled Trials as Topic; D011795:Surveys and Questionnaires; D013535:Suspensions / Q000008:administration & dosage / Q000493:pharmacokinetics; D016896:Treatment Outcome
D002511:Cephalosporins; D013535:Suspensions; D019980:Amoxicillin-Potassium Clavulanate Combination; D000077525:Cefdinir