Efficacy of cefixime in the treatment of acute otitis media in children.

OBJECTIVE

To compare the efficacy of cefixime with amoxicillin in the treatment of acute otitis media in children.

DESIGN

Randomized, nonblinded study.

SETTING

General pediatric clinic at a university hospital in Texas.

PARTICIPANTS

A volunteer sample of 201 children, aged 2 months through 6 years.

INTERVENTIONS

A 10-day oral course of cefixime (8 mg/kg per day administered once daily) or amoxicillin (40 mg/kg per day administered in three divided doses [every 8 hours]).

MEASUREMENTS/MAIN RESULTS: Tympanocentesis for bacterial culture was performed on all affected ears on enrollment and after 4 to 6 days of therapy. The patients were evaluated clinically 4 to 6 days after starting therapy, at the end of therapy, and 3 to 4 weeks after therapy was completed. Using Fisher's Exact Test, no significant difference was found between the two treatment groups for rate of clinical improvement or rate of eradication of Haemophilus influenzae and Streptococcus pneumoniae. However, combining the results from this study and two previously reported studies, cefixime was found to be more effective in eradication of H influenzae and less effective in eradication of S pneumoniae.