A comparison of 5 days of therapy with cefdinir or azithromycin in children with acute otitis media: a multicenter, prospective, single-blind study.
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.
Block
Stan L
SL
Kentucky Pediatric/Adult Research, Bardstown, 40004, USA. slblock@pol.net
Cifaldi
Mary
M
Gu
Yihua
Y
Paris
Maria M
MM
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
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