BACKGROUND: The pharmacokinetic profile of azithromycin supports its use as single-dose therapy for uncomplicated acute otitis media (AOM) in children. OBJECTIVE: This study was designed to (1) compare the safety of single-dose oral azithromycin, 3 daily doses of oral azithromycin, and a single dose of intramuscular ceftriaxone for the treatment of uncomplicated AOM in children, and (2) provide preliminary efficacy data to support initiation of a larger, comparative trial of single-dose azithromycin for the treatment of uncomplicated acute otitis media in children. METHODS: In this single-center pilot study, children with uncomplicated AOM were randomly assigned to receive single-dose oral azithromycin (30 mg/kg), 3-day oral azithromycin (10 mg/kg once daily), or single-dose intramuscular ceftriaxone (50 mg/kg). Tympanocentesis was performed before administration of the first dose, and clinical response was assessed on days 14-15 and 28-30. RESULTS:Between September 1995 and May 1997, 198 children (mean age, 2.5 years) were enrolled. All of the patients were evaluable for the safety and clinical intent-to-treat (ITT) analyses, and 98 were evaluable for the microbiologic ITT analysis. On day 14-15, rates of clinical success (cure or improvement) for the 3 treatment groups were: 62/64 (97%) for single-dose azithromycin, 60/63 (95%) for 3-day azithromycin, and 61/62 (98%) for single-dose ceftriaxone. On day 28-30, the corresponding clinical success rates were 61/65 (94%), 61/66 (92%), and 62/64 (97%). For the 98 microbiologically evaluable patients, clinical success rates at day 14-15 were 28/30 (93%) for single-dose azithromycin, 31/35 (89%) for 3-day azithromycin, and 33/33 (100%) for single-dose ceftriaxone. On day 28-30, the corresponding clinical success rates were 27/30 (90%), 30/35 (86%), and 32/33 (97%). Treatment-related adverse event rates for single-dose azithromycin, 3-day azithromycin, and single-dose ceftriaxone were 10.6%, 9.1%, and 9.1%, respectively. CONCLUSION: In this pilot study comparing single-dose azithromycin, 3-day azithromycin, and single-dose ceftriaxone for the treatment of uncomplicated AOM in children, no differences were detected among the 3 regimens.
RCT Entities:
BACKGROUND: The pharmacokinetic profile of azithromycin supports its use as single-dose therapy for uncomplicated acute otitis media (AOM) in children. OBJECTIVE: This study was designed to (1) compare the safety of single-dose oral azithromycin, 3 daily doses of oral azithromycin, and a single dose of intramuscular ceftriaxone for the treatment of uncomplicated AOM in children, and (2) provide preliminary efficacy data to support initiation of a larger, comparative trial of single-dose azithromycin for the treatment of uncomplicated acute otitis media in children. METHODS: In this single-center pilot study, children with uncomplicated AOM were randomly assigned to receive single-dose oral azithromycin (30 mg/kg), 3-day oral azithromycin (10 mg/kg once daily), or single-dose intramuscular ceftriaxone (50 mg/kg). Tympanocentesis was performed before administration of the first dose, and clinical response was assessed on days 14-15 and 28-30. RESULTS: Between September 1995 and May 1997, 198 children (mean age, 2.5 years) were enrolled. All of the patients were evaluable for the safety and clinical intent-to-treat (ITT) analyses, and 98 were evaluable for the microbiologic ITT analysis. On day 14-15, rates of clinical success (cure or improvement) for the 3 treatment groups were: 62/64 (97%) for single-dose azithromycin, 60/63 (95%) for 3-day azithromycin, and 61/62 (98%) for single-dose ceftriaxone. On day 28-30, the corresponding clinical success rates were 61/65 (94%), 61/66 (92%), and 62/64 (97%). For the 98 microbiologically evaluable patients, clinical success rates at day 14-15 were 28/30 (93%) for single-dose azithromycin, 31/35 (89%) for 3-day azithromycin, and 33/33 (100%) for single-dose ceftriaxone. On day 28-30, the corresponding clinical success rates were 27/30 (90%), 30/35 (86%), and 32/33 (97%). Treatment-related adverse event rates for single-dose azithromycin, 3-day azithromycin, and single-dose ceftriaxone were 10.6%, 9.1%, and 9.1%, respectively. CONCLUSION: In this pilot study comparing single-dose azithromycin, 3-day azithromycin, and single-dose ceftriaxone for the treatment of uncomplicated AOM in children, no differences were detected among the 3 regimens.
Authors: R Cohen; M Navel; J Grunberg; M Boucherat; P Geslin; M Derriennic; F Pichon; J M Goehrs Journal: Pediatr Infect Dis J Date: 1999-05 Impact factor: 2.129
Authors: S F Dowell; J C Butler; G S Giebink; M R Jacobs; D Jernigan; D M Musher; A Rakowsky; B Schwartz Journal: Pediatr Infect Dis J Date: 1999-01 Impact factor: 2.129
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