title: Five vs. ten days of antibiotic therapy for acute otitis media in young children.
abstract: BACKGROUND
  Many publications in recent years have argued in favor of shortened therapy for acute otitis media. However, doubt persists regarding children younger than 2 years, and some authors therefore restrict short course therapy to children older than 2 years.
  
  
  METHODS
  In a prospective, comparative, double blind, randomized, multicenter trial we compared cefpodoxime-proxetil, 8 mg/kg/day in two divided doses for 10 days, with an identical 5-day regimen followed by a 5-day placebo period.
  
  
  RESULTS
  Between October, 1996, and April, 1997, 450 children (mean age, 14.3 months) were enrolled, 227 in the 5-day group and 223 in the 10-day group. In the per protocol analysis clinical success was obtained on Days 12 to 14 after the beginning of treatment (main analysis) in 175 (84.1%) of the 208 children receiving the 5-day regimen and 194 (92.4%) of the 210 children receiving the 10-day regimen (P = 0.009). The superiority of the standard regimen was more marked among children cared for outside their homes (92.5% vs. 81.5%). Clinical success persisted on Days 28 to 42 among 134 (85.4%) of the 157 assessable patients in the 5-day group and 144 (83.7%) of the 172 assessable patients in the 10-day group (P = 0.68).
  
  
  CONCLUSIONS
  The 10-day regimen resulted in a higher success rate at the conclusion of therapy, but there were no differences between the two study groups 4 to 6 weeks after enrollment in the study protocol.
authors.affiliation: Department of Microbiology and Pediatrics, Intercommunal Hospital of Créteil, France. robert.cohen@wanadoo.fr
authors.forename: R
authors.initials: R
authors.lastname: Cohen
authors.forename: C
authors.initials: C
authors.lastname: Levy
authors.forename: M
authors.initials: M
authors.lastname: Boucherat
authors.forename: J
authors.initials: J
authors.lastname: Langue
authors.forename: E
authors.initials: E
authors.lastname: Autret
authors.forename: P
authors.initials: P
authors.lastname: Gehanno
authors.forename: F
authors.initials: F
authors.lastname: de La Rocque
mesh_terms: D000208:Acute Disease; D000900:Anti-Bacterial Agents / Q000008:administration & dosage* / Q000009:adverse effects; D015296:Ceftizoxime / Q000008:administration & dosage* / Q000009:adverse effects / Q000031:analogs & derivatives; D002675:Child, Preschool; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D006193:Haemophilus influenzae / Q000145:classification / Q000302:isolation & purification; D006801:Humans; D007223:Infant; D008297:Male; D001936:Moraxella catarrhalis / Q000145:classification / Q000302:isolation & purification; D015999:Multivariate Analysis; D010033:Otitis Media / Q000188:drug therapy* / Q000382:microbiology; D011355:Prodrugs / Q000008:administration & dosage* / Q000009:adverse effects; D011446:Prospective Studies; D012703:Serotyping; D013296:Streptococcus pneumoniae / Q000145:classification / Q000302:isolation & purification; D016896:Treatment Outcome; D000097627:Cefpodoxime Proxetil
chemical_list: D000900:Anti-Bacterial Agents; D015296:Ceftizoxime; D011355:Prodrugs; D000097627:Cefpodoxime Proxetil