title: A comparison of 5 days of therapy with cefdinir or azithromycin in children with acute otitis media: a multicenter, prospective, single-blind study.
abstract: BACKGROUND
  Short-course therapy for acute otitis media (AOM) improves adherence and may reduce secondary bacterial resistance.
  
  
  METHODS
  In this multicenter, prospective, investigator-blinded study, patients between the ages of 6 months and 6 years with a clinical diagnosis of AOM were randomized to receive cefdinir oral suspension 7 mg/kg q12h for 5 days or azithromycin oral suspension 10 mg/kg once daily on day 1 and 5 mg/kg once daily on days 2 through 5. Clinical response was assessed at the end-of-therapy (EOT) visit (days 7-9) and the follow-up visit (days 20-25).
  
  
  RESULTS
  Three hundred fifty-seven patients were enrolled in the study. The treatment groups were similar at baseline with respect to demographic characteristics (mean [SD] age, 3.0 [1.7] years; 55% male), incidence of bilateral AOM (45%), and presenting signs and symptoms. The majority of evaluable children (77%) had previously received conjugated heptavalent pneumococcal vaccine (PCV7) against Streptococcus pneumoniae. At the EOT visit, clinical cure rates were comparable for cefdinir and azithromycin (87% [151/174] and 85% [149/176], respectively; 95% CI, -5.5 to 9.8). In addition, clinical cure rates at the EOT visit in the children who had been vaccinated with PCV7 were comparable between cefdinir and azithromycin (86% vs 83%; 95% CI, -6.5 to 11.8). No significant difference in clinical cure rates was observed at the follow-up visit (76% and 86%; 95% CI, -18.9 to 0.0). Parental satisfaction was similar between treatment groups with regard to ease of use, taste, compliance, health care resource utilization, and missed days of work and day-care. Both antibiotics were well tolerated; diarrhea and abnormal stools were the most common antibiotic-related adverse events (< or = 7% each).
  
  
  CONCLUSIONS
  Short courses (5 days) of therapy with cefdinir or azithromycin were comparable in these children with AOM based on clinical end points, parental preferences, and health care utilization.
authors.affiliation: Kentucky Pediatric/Adult Research, Bardstown, 40004, USA. slblock@pol.net
authors.forename: Stan L
authors.initials: SL
authors.lastname: Block
authors.forename: Mary
authors.initials: M
authors.lastname: Cifaldi
authors.forename: Yihua
authors.initials: Y
authors.lastname: Gu
authors.forename: Maria M
authors.initials: MM
authors.lastname: Paris
mesh_terms: D000158:Acoustic Impedance Tests / Q000379:methods; D000208:Acute Disease; D000284:Administration, Oral; D000700:Analgesics / Q000627:therapeutic use; D018712:Analgesics, Non-Narcotic / Q000627:therapeutic use; D000890:Anti-Infective Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D000893:Anti-Inflammatory Agents / Q000627:therapeutic use; D017963:Azithromycin / 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; D003967:Diarrhea / Q000139:chemically induced; D004334:Drug Administration Schedule; D005260:Female; D000069443:Heptavalent Pneumococcal Conjugate Vaccine; D006801:Humans; D008297:Male; D022401:Meningococcal Vaccines / Q000008:administration & dosage / Q000276:immunology; D010033:Otitis Media / Q000188:drug therapy* / Q000503:physiopathology; D022242:Pneumococcal Vaccines / Q000008:administration & dosage / Q000276:immunology; D011446:Prospective Studies; D016037:Single-Blind Method; D013296:Streptococcus pneumoniae / Q000187:drug effects / Q000254:growth & development; D013997:Time Factors; D016896:Treatment Outcome; D014432:Tympanic Membrane / Q000187:drug effects / Q000503:physiopathology
chemical_list: D000700:Analgesics; D018712:Analgesics, Non-Narcotic; D000890:Anti-Infective Agents; D000893:Anti-Inflammatory Agents; D002511:Cephalosporins; D000069443:Heptavalent Pneumococcal Conjugate Vaccine; D022401:Meningococcal Vaccines; D022242:Pneumococcal Vaccines; D017963:Azithromycin; D000077525:Cefdinir