title: Five-day twice daily cefdinir therapy for acute otitis media: microbiologic and clinical efficacy.
abstract: 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).
  
  
  METHODS
  Open label noncomparative trial.
  
  
  METHODS
  Primary care, ambulatory.
  
  
  METHODS
  Children ages 6 months through 12 years with signs of AOM and middle ear effusion confirmed by tympanometry in at least one ear.
  
  
  METHODS
  Patients underwent tympanocentesis at baseline and received cefdinir 7 mg/kg twice a day for 5 days.
  
  
  METHODS
  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.
authors.affiliation: Kentucky Pediatric Research, Bardstown, USA.
authors.forename: S L
authors.initials: SL
authors.lastname: Block
authors.forename: J A
authors.initials: JA
authors.lastname: Hedrick
authors.forename: J
authors.initials: J
authors.lastname: Kratzer
authors.forename: M A
authors.initials: MA
authors.lastname: Nemeth
authors.forename: K J
authors.initials: KJ
authors.lastname: Tack
mesh_terms: D000158:Acoustic Impedance Tests; D000208:Acute Disease; D001424:Bacterial Infections / Q000188:drug therapy / Q000382:microbiology; D000077525:Cefdinir; D002511:Cephalosporins / Q000494:pharmacology / Q000627:therapeutic use*; D002648:Child; D002675:Child, Preschool; D005260:Female; D006193:Haemophilus influenzae / Q000187:drug effects / Q000302:isolation & purification; D006801:Humans; D007223:Infant; D008297:Male; D008826:Microbial Sensitivity Tests; D001936:Moraxella catarrhalis / Q000187:drug effects / Q000302:isolation & purification; D010033:Otitis Media / Q000175:diagnosis / Q000188:drug therapy* / Q000382:microbiology*; D010034:Otitis Media with Effusion / Q000175:diagnosis / Q000188:drug therapy; D010403:Penicillin Resistance; D013296:Streptococcus pneumoniae / Q000187:drug effects / Q000302:isolation & purification; D013297:Streptococcus pyogenes / Q000187:drug effects / Q000302:isolation & purification; D016896:Treatment Outcome
chemical_list: D002511:Cephalosporins; D000077525:Cefdinir