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High-dose azithromycin versus high-dose amoxicillin-clavulanate for treatment of children with recurrent or persistent acute otitis media.
Antimicrob Agents Chemother 2003; 47(10):3179-86AA

Abstract

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 < or =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 < or =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 < or =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.

Authors+Show Affiliations

Children's Hospital of Orange County, Orange, California, USA.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

14506028

Citation

Arrieta, Antonio, et al. "High-dose Azithromycin Versus High-dose Amoxicillin-clavulanate for Treatment of Children With Recurrent or Persistent Acute Otitis Media." Antimicrobial Agents and Chemotherapy, vol. 47, no. 10, 2003, pp. 3179-86.
Arrieta A, Arguedas A, Fernandez P, et al. High-dose azithromycin versus high-dose amoxicillin-clavulanate for treatment of children with recurrent or persistent acute otitis media. Antimicrob Agents Chemother. 2003;47(10):3179-86.
Arrieta, A., Arguedas, A., Fernandez, P., Block, S. L., Emperanza, P., Vargas, S. L., ... Rothermel, C. D. (2003). High-dose azithromycin versus high-dose amoxicillin-clavulanate for treatment of children with recurrent or persistent acute otitis media. Antimicrobial Agents and Chemotherapy, 47(10), pp. 3179-86.
Arrieta A, et al. High-dose Azithromycin Versus High-dose Amoxicillin-clavulanate for Treatment of Children With Recurrent or Persistent Acute Otitis Media. Antimicrob Agents Chemother. 2003;47(10):3179-86. PubMed PMID: 14506028.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - High-dose azithromycin versus high-dose amoxicillin-clavulanate for treatment of children with recurrent or persistent acute otitis media. AU - Arrieta,Antonio, AU - Arguedas,Adriano, AU - Fernandez,Pilar, AU - Block,Stan L, AU - Emperanza,Paz, AU - Vargas,Sergio L, AU - Erhardt,William A, AU - de Caprariis,Pascal J, AU - Rothermel,Constance D, PY - 2003/9/25/pubmed PY - 2004/3/9/medline PY - 2003/9/25/entrez SP - 3179 EP - 86 JF - Antimicrobial agents and chemotherapy JO - Antimicrob. Agents Chemother. VL - 47 IS - 10 N2 - 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 < or =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 < or =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 < or =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. SN - 0066-4804 UR - https://www.unboundmedicine.com/medline/citation/14506028/High_dose_azithromycin_versus_high_dose_amoxicillin_clavulanate_for_treatment_of_children_with_recurrent_or_persistent_acute_otitis_media_ L2 - http://aac.asm.org/cgi/pmidlookup?view=long&amp;pmid=14506028 DB - PRIME DP - Unbound Medicine ER -