title: A multicenter, open label, double tympanocentesis study of high dose cefdinir in children with acute otitis media at high risk of persistent or recurrent infection.
abstract: BACKGROUND
  Given the relatively high prevalence of recurrent and persistent acute otitis media (AOM) and the prominent etiologic role of Streptococcus pneumoniae, especially penicillin-nonsusceptible strains in children with these conditions, new alternative treatments are desirable.
  
  
  METHODS
  Children 6 months-4 years of age with AOM considered to be at risk for recurrent or persistent infection received large dosage cefdinir 25 mg/kg oral suspension once daily for 10 days. Children were evaluated pretreatment (day 1), on therapy (days 4-6), end of therapy (days 12-14) and at follow-up (days 25-28). All children had tympanocentesis at enrollment. In culture-positive children, tympanocentesis was repeated after 3-5 days (days 4-6) unless evidence of absence of middle ear effusion was documented.
  
  
  RESULTS
  Of 447 children enrolled, 230 were clinically and bacteriologically evaluable (74% 2 years old or younger; 57% treated for AOM in previous 3 months). Bacteriologic eradication, based on repeat tympanocentesis on days 4-6, was achieved in 74% (170 of 230) of children; 76% (201 of 266) of AOM pathogens were eradicated. Eradication of penicillin-susceptible, -intermediate and -resistant S. pneumoniae was 91% (50 of 55), 67% (18 of 27) and 43% (10 of 23), respectively (P < 0.001); eradication of H. influenzae was 72% (90 of 125). Overall clinical response at days 12-14 was 83% (76 and 82% for children with S. pneumoniae and Haemophilus influenzae, respectively). Sustained clinical response at days 25-28 was 85%. Clinical response was 83% for culture-positive children versus 96% for culture-negative children at baseline tympanocentesis (P < 0.001).
  
  
  CONCLUSIONS
  In this study of AOM among children at risk for persistent or recurrent infection, large dose cefdinir resulted in an overall successful clinical response at end of treatment of 83%. This regimen was efficacious against penicillin-susceptible S. pneumoniae, but effectiveness was markedly decreased against nonsusceptible strains and was moderate for H. influenzae strains.
authors.affiliation: Instituto de Atención Pediátrica, Neeman-ICIC, Hospital Nacional de Niños, San José, Costa Rica. aarguedas@iped.net
authors.forename: Adriano
authors.initials: A
authors.lastname: Arguedas
authors.forename: Ron
authors.initials: R
authors.lastname: Dagan
authors.forename: Eugene
authors.initials: E
authors.lastname: Leibovitz
authors.forename: Alejandro
authors.initials: A
authors.lastname: Hoberman
authors.forename: Michael
authors.initials: M
authors.lastname: Pichichero
authors.forename: Maria
authors.initials: M
authors.lastname: Paris
mesh_terms: D000208:Acute Disease; D000284:Administration, Oral; D000890:Anti-Infective Agents / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D000077525:Cefdinir; D002511:Cephalosporins / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D002675:Child, Preschool; D005260:Female; D006801:Humans; D007223:Infant; D008297:Male; D008826:Microbial Sensitivity Tests; D010034:Otitis Media with Effusion / Q000188:drug therapy* / Q000382:microbiology; D019152:Paracentesis / Q000379:methods; D010403:Penicillin Resistance; D011008:Pneumococcal Infections / Q000188:drug therapy / Q000382:microbiology; D012008:Recurrence; D012307:Risk Factors; D013296:Streptococcus pneumoniae / Q000187:drug effects; D016896:Treatment Outcome
chemical_list: D000890:Anti-Infective Agents; D002511:Cephalosporins; D000077525:Cefdinir