S McLinn1. 1. Scottsdale Pediatric Center, AZ 85260-6743, USA.
Abstract
OBJECTIVE: To compare the efficacy and safety of azithromycin and amoxicillin/clavulanate in pediatric acute otitis media. METHODS: Investigators from 12 US centers recruited 677 children. In a randomized, double blind, double dummy fashion, participants received either azithromycin suspension (n = 341) once daily for 5 days or amoxicillin/clavulanate suspension (n = 336) in three divided doses daily for 10 days. RESULTS: Among evaluable patients satisfactory clinical response rates (cured and improved) measured 11 days after therapy began were 87.5% in the azithromycin group and 87.9% in the amoxicillin/clavulanate group; corresponding rates at 30 days were 73.5% in the azithromycin and 71.2% in the amoxicillin/clavulanate groups. Relapse rates were comparable for the treatment groups. Treatment-related side effects, primarily gastrointestinal, were reported significantly less frequently with azithromycin (8.8%) than with amoxicillin/clavulanate (30.8%) (P < 0.0001). Two (0.6%) azithromycin patients and 12 (3.6%) amoxicillin/ clavulanate patients discontinued therapy because of treatment-related side effects (P < 0.006 between groups). CONCLUSIONS: In these children with acute otitis media, azithromycin given once daily for 5 days and amoxicillin/clavulanate given three times daily for 10 days had similar efficacy; however, azithromycin was significantly better tolerated.
RCT Entities:
OBJECTIVE: To compare the efficacy and safety of azithromycin and amoxicillin/clavulanate in pediatric acute otitis media. METHODS: Investigators from 12 US centers recruited 677 children. In a randomized, double blind, double dummy fashion, participants received either azithromycin suspension (n = 341) once daily for 5 days or amoxicillin/clavulanate suspension (n = 336) in three divided doses daily for 10 days. RESULTS: Among evaluable patients satisfactory clinical response rates (cured and improved) measured 11 days after therapy began were 87.5% in the azithromycin group and 87.9% in the amoxicillin/clavulanate group; corresponding rates at 30 days were 73.5% in the azithromycin and 71.2% in the amoxicillin/clavulanate groups. Relapse rates were comparable for the treatment groups. Treatment-related side effects, primarily gastrointestinal, were reported significantly less frequently with azithromycin (8.8%) than with amoxicillin/clavulanate (30.8%) (P < 0.0001). Two (0.6%) azithromycinpatients and 12 (3.6%) amoxicillin/ clavulanatepatients discontinued therapy because of treatment-related side effects (P < 0.006 between groups). CONCLUSIONS: In these children with acute otitis media, azithromycin given once daily for 5 days and amoxicillin/clavulanate given three times daily for 10 days had similar efficacy; however, azithromycin was significantly better tolerated.
Authors: Antonio Arrieta; Adriano Arguedas; Pilar Fernandez; Stan L Block; Paz Emperanza; Sergio L Vargas; William A Erhardt; Pascal J de Caprariis; Constance D Rothermel Journal: Antimicrob Agents Chemother Date: 2003-10 Impact factor: 5.191
Authors: Michael W Dunne; Chandra Khurana; Adriano Arguedas Mohs; Adib Rodriguez; Antonio Arrieta; Samuel McLinn; Judy A Krogstad; Mark Blatter; Richard Schwartz; Sergio L Vargas; Paz Emparanza; Pilar Fernandez; Willis M Gooch; Mary Aspin; John Podgore; Irmeli Roine; Jeffrey L Blumer; Garth D Ehrlich; Jean Chow Journal: Antimicrob Agents Chemother Date: 2003-08 Impact factor: 5.191
Authors: Adriano Arguedas; Cecilia Loaiza; Alexandra Perez; Alvaro Gutierrez; Marco Luis Herrera; Constance D Rothermel Journal: Curr Ther Res Clin Exp Date: 2003