Sl. Block et al., Five-day twice daily cefdinir therapy for acute otitis media: microbiologic and clinical efficacy, PEDIAT INF, 19(12), 2000, pp. S153-S158
Objective. To examine the microbiologic and clinical efficacy of a 5-day co
urse of cefdinir in the treatment of tympanocentesis-documented acute otiti
s media (AOM),
Design. Open label noncomparative trial.
Setting, Primary care, ambulatory,
Patients. Children ages 6 months through 12 years with signs of AOM and mid
dle ear effusion confirmed by tympanometry in at least one ear.
Intervention. Patients underwent tympanocentesis at baseline and received c
efdinir 7 mg/kg twice a day for 5 days.
Main outcome measures. Presumptive eradication of middle ear pathogens dete
rmined by clinical cure of signs and symptoms of AOM at end of therapy (Stu
dy 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 infl
uenzae 44 (32.8%; beta-lactamase-positive in 18 of 44 strains); beta-lactam
ase-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 6
1.9% (104 of 168) at Visit 3, Presumptive eradication rates at end of thera
py were 8 of 11 (72.7%) and 4 of 8 (50%) for patients with penicillin-inter
mediate and -resistant S, pneumoniae isolates, respectively. Adverse reacti
ons occurred in 16% of patients, with diarrhea (11%) occurring most frequen
tly.
Conclusions. A 5-day regimen of cefdinir was effective in the eradication-o
f the common causative pathogens of nonrefractory AOM, including intermedia
te penicillin-resistant S, pneumoniae and beta-lactamase-producing organism
s. Cefdinir should be considered a suitable second line antibiotic for AOM.