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Antimicrobial Agents and Chemotherapy, October 2003, p. 3179-3186, Vol. 47, No. 10
0066-4804/03/$08.00+0     DOI: 10.1128/AAC.47.10.3179-3186.2003
Copyright © 2003, American Society for Microbiology. All Rights Reserved.

High-Dose Azithromycin versus High-Dose Amoxicillin-Clavulanate for Treatment of Children with Recurrent or Persistent Acute Otitis Media

Antonio Arrieta,1 Adriano Arguedas,2 Pilar Fernandez,3 Stan L. Block,4 Paz Emperanza,5 Sergio L. Vargas,6 William A. Erhardt,7 Pascal J. de Caprariis,7 and Constance D. Rothermel7*

Children's Hospital of Orange County, Orange, California,1 Neeman-ICIC, San Jose, Costa Rica,2 Hospital Clinico Universidad de Chile,3 Otomed-Servicio Otorrinolaringologia,5 Grupo de Estudios Clinicos, Facultad de Medicina Universidad de Chile, Santiago, Chile,6 Kentucky Pediatric Research, Bardstown, Kentucky,4 Pfizer Inc., New York, New York7

Received 18 April 2003/ Returned for modification 2 June 2003/ Accepted 21 July 2003

Infants and young children, especially those in day care, are at risk for recurrent or persistent acute otitis media (AOM). There are no data on oral alternatives to high-dose amoxicillin-clavulanate for treating AOM in these high-risk patients. In this double-blind, double-dummy multicenter clinical trial, we compared a novel, high-dose azithromycin regimen with high-dose amoxicillin-clavulanate for treatment of children with recurrent or persistent AOM. Three hundred four children were randomized; 300 received either high-dose azithromycin (20 mg/kg of body weight once a day for 3 days) or high-dose amoxicillin-clavulanate (90 mg/kg divided twice a day for 10 days). Tympanocentesis was performed at baseline; clinical response was assessed at day 12 to 16 and day 28 to 32. Two-thirds of patients were aged <=2 years. A history of recurrent, persistent, or recurrent plus persistent AOM was noted in 67, 18, and 14% of patients, respectively. Pathogens were isolated from 163 of 296 intent-to-treat patients (55%). At day 12 to 16, clinical success rates for azithromycin and amoxicillin-clavulanate were comparable for all patients (86 versus 84%, respectively) and for children aged <=2 years (85 versus 79%, respectively). At day 28 to 32, clinical success rates for azithromycin were superior to those for amoxicillin-clavulanate for all patients (72 versus 61%, respectively; P = 0.047) and for those aged <=2 years (68 versus 51%, respectively; P = 0.017). Per-pathogen clinical efficacy against Streptococcus pneumoniae and Haemophilus influenzae was comparable between the two regimens. The rates of treatment-related adverse events for azithromycin and amoxicillin-clavulanate were 32 and 42%, respectively (P = 0.095). Corresponding compliance rates were 99 and 93%, respectively (P = 0.018). These data demonstrate the efficacy and safety of high-dose azithromycin for treating recurrent or persistent AOM.

* Corresponding author. Mailing address: Pfizer Inc., 235 East 42nd St., New York, NY 10017. Phone: (212) 733-6117. Fax: (212) 309-4579. E-mail: Constance.Rothermel{at}Pfizer.com.

Antimicrobial Agents and Chemotherapy, October 2003, p. 3179-3186, Vol. 47, No. 10
0066-4804/03/$08.00+0     DOI: 10.1128/AAC.47.10.3179-3186.2003
Copyright © 2003, American Society for Microbiology. All Rights Reserved.



This article has been cited by other articles:

  • Block, S L (2006). Searching for the Holy Grail of acute otitis media.. Arch. Dis. Child. 91: 959-961 [Full Text]  
  • Hoberman, A., Paradise, J. L., Jacobs, M. R., Dagan, R., Singer, M. E., Arrieta, A., Arguedas, A., Block, S. L., Vargas, S. L., Erhardt, W. A., de Caprariis, P. J. (2004). Study Design Questions in Treatment of Children with Acute Otitis Media. Antimicrob. Agents Chemother. 48: 2784-2786 [Full Text]  


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