This was a noncomparative, open label multicenter trial. Children ages 6 months to 12 years with signs and symptoms of AOM and evidence of
middle ear effusion, as confirmed by pneumatic otoscopy or tympanometry, underwent tympanocentesis and subsequent treatment with
cefprozil (15 mg/kg given twice daily) for 10 days. Patients with recurrent
otitis media or failure of previous
antibiotic therapy or prophylaxis were particularly sought for the study.
RESULTS: Two hundred sixty-two (99%) of 265 enrolled children were considered evaluable. The median age of the study group was 1 year. Ninety-eight (37%) of the children had a history (within 30 days) of prior
antibiotic use. Ninety-seven (37%) met our definition of recurrent AOM, 48 (18%) met our definition of persistent AOM and 132 (50%) children had 3 or more previous episodes of acute
otitis media within 12 months before study. Eighty-two (31%) of the enrollment tympanocentesis had no growth, 150 (57%) had a single bacterial pathogen and 29 (11%) had multiple bacterial pathogens. Of the 93 Streptococcus pneumoniae pretreatment isolates, 50 (54%) were
penicillin-susceptible, 12 (13%) were
penicillin-intermediate resistant and 31 (33%) were
penicillin-resistant. Of the 75 Haemophilus influenzae pretreatment isolates, 42 (56%) produced
beta-lactamase as did 4 (27%) of the 15 Moraxella catarrhalis strains. A satisfactory clinical response by pathogen was found in 75% (70 of 93) with S. pneumoniae, 75% (56 of 75) with H. influenzae and 93% (13 of 14) with M. catarrhalis; the response with single pathogen
infections was higher than those with multiple pathogens (118 of 150 (78%) and 17 of 29 (59%), respectively; P = 0.03). The response for patients with isolates of S. pneumoniae that were
penicillin-susceptible, -intermediate or -resistant were 39 of 50 (78%), 11 of 12 (92%) and 21 of 31 (68%), respectively. Older children had a satisfactory clinical outcome more frequently than younger children (P < 0.001), and the response to
therapy varied for persistent, recurrent and recently untreated AOM (P < 0.01).
CONCLUSION: Persistent and recurrent AOM involves the same pathogens as recently untreated AOM but bacteria with reduced
antibiotic susceptibility may be more frequently present. This noncomparative study suggests that
cefprozil 30 mg/kg/day given in two divided doses for 10 days may be effective in the treatment of children with persistent and recurrent AOM.