Five-day twice daily cefdinir therapy for acute otitis media: microbiologic and clinical efficacy.

Objective. To examine the microbiologic and clinical efficacy of a 5-day course of cefdinir in the treatment of tympanocentesis-documented acute otitis media (AOM), Design. Open label noncomparative trial. Setting, Primary care, ambulatory, Patients. Children ages 6 months through 12 years with signs of AOM and middle ear effusion confirmed by tympanometry in at least one ear. Intervention. Patients underwent tympanocentesis at baseline and received cefdinir 7 mg/kg twice a day for 5 days. Main outcome measures. Presumptive eradication of middle ear pathogens determined by clinical cure of signs and symptoms of AOM at end of therapy (Study Days 7 to 9) and Visit 3 (Study Days 16 to 21), Results. A total of 125 of 177 enrolled children had 134 pathogens isolated by tympanocentesis: Streptococcus pneumoniae, 69 (51.5%); Haemophilus influenzae 44 (32.8%; beta-lactamase-positive in 18 of 44 strains); beta-lactamase-positive Moraxella catarrhalis, 15 (11.2%); and Streptococcus pyogenes, 6 (4.5%), The clinical cure rates by patient in the microbiologically and overall clinically evaluable groups, respectively, were 73% (84 of 115) and 77.4% (130 of 168) at the end of therapy visit and 57.4% (66 of 115) and 61.9% (104 of 168) at Visit 3, Presumptive eradication rates at end of therapy were 8 of 11 (72.7%) and 4 of 8 (50%) for patients with penicillin-intermediate and -resistant S, pneumoniae isolates, respectively. Adverse reactions occurred in 16% of patients, with diarrhea (11%) occurring most frequently. Conclusions. A 5-day regimen of cefdinir was effective in the eradication-of the common causative pathogens of nonrefractory AOM, including intermediate penicillin-resistant S, pneumoniae and beta-lactamase-producing organisms. Cefdinir should be considered a suitable second line antibiotic for AOM.