Stan L Block1, Antonio Arrieta2, Matthew Seibel3, Samuel McLinn4, Stephen Eppes5, Mary J Murphy6. 1. Kentucky Pediatric Research, Bardstown, Kentucky. 2. Division of Infectious Disease, Children's Hospital of Orange County, Orange, California. 3. Arnold Palmer Hospital for Children and Women, Orlando, Florida. 4. Scottsdale Pediatric Center, Scottsdale, Arizona. 5. Division of Infectious Diseases, Jefferson Medical College and duPont Hospital for Children, Wilmington, Delaware, and. 6. Pfizer Inc, New York, New York, USA.
Abstract
BACKGROUND: The long half-life of azithromycin allows for single-dose oral therapy for acute otitis media (AOM). OBJECTIVE: This study was designed to compare the efficacy and tolerability of single-dose azithromycin with 10-day, twice-daily amoxicillin/clavulanate for the treatment of new-onset, uncomplicated AOM in children. METHODS:Children aged 6 months to 12 years with new-onset AOM were randomly assigned to receive either a single 30-mg/kg dose of azithromycin or standard-dose amoxicillin/clavulanate (45 mg/kg administered BID for 10 days) in a double-blind, double-placebo, multicenter clinical trial. The diagnosis of AOM was based on specific clinical signs and symptoms, and was confirmed by pneumatic otoscopy and acoustic reflectometry (level ≥3). Clinical response was assessed on days 12-16 and 28-32. RESULTS:Mean (SD) age of children receiving azithromycin (n = 173) or amoxicillin/clavulanate (n = 173) was 2.7 (2.3) years and 3.4 (2.8) years, respectively, with 43% and 36% ≤2 years of age. Most (53.2%) of the children were boys, and most (51.2%) were white. Clinical success rates (intent-to-treat) for azithromycin and amoxicillin/clavulanate, respectively, were 87% and 88% (95% CI, -9.2 to 6.5) on day 12-16 and 75% and 75% (95% CI, -10.2 to 10.5) on day 28-32. The incidences of treatment-related adverse events for azithromycin and amoxicillin/clavulanate were 16.8% and 22.5%, respectively. Corresponding rates of diarrhea were 6.4% and 12.7%, respectively. Vomiting, which was generally mild, occurred in 7 children in each group. One azithromycin patient and 5 amoxicillin/clavulanate patients discontinued treatment because of adverse events. The compliance rate for azithromycin was significantly higher than that for amoxicillin/clavulanate (99% vs 83%; P<0.001). CONCLUSIONS: In this trial comparing the efficacy of single-dose azithromycin (30 mg/kg) with twice-daily amoxicillin/clavulanate (45 mg/kg) for the treatment of new-onset, uncomplicated AOM, no differences were detected between the 2 regimens. Single-dose azithromycin was generally well tolerated and provides an alternative to conventional oral regimens for AOM.
RCT Entities:
BACKGROUND: The long half-life of azithromycin allows for single-dose oral therapy for acute otitis media (AOM). OBJECTIVE: This study was designed to compare the efficacy and tolerability of single-dose azithromycin with 10-day, twice-daily amoxicillin/clavulanate for the treatment of new-onset, uncomplicated AOM in children. METHODS:Children aged 6 months to 12 years with new-onset AOM were randomly assigned to receive either a single 30-mg/kg dose of azithromycin or standard-dose amoxicillin/clavulanate (45 mg/kg administered BID for 10 days) in a double-blind, double-placebo, multicenter clinical trial. The diagnosis of AOM was based on specific clinical signs and symptoms, and was confirmed by pneumatic otoscopy and acoustic reflectometry (level ≥3). Clinical response was assessed on days 12-16 and 28-32. RESULTS: Mean (SD) age of children receiving azithromycin (n = 173) or amoxicillin/clavulanate (n = 173) was 2.7 (2.3) years and 3.4 (2.8) years, respectively, with 43% and 36% ≤2 years of age. Most (53.2%) of the children were boys, and most (51.2%) were white. Clinical success rates (intent-to-treat) for azithromycin and amoxicillin/clavulanate, respectively, were 87% and 88% (95% CI, -9.2 to 6.5) on day 12-16 and 75% and 75% (95% CI, -10.2 to 10.5) on day 28-32. The incidences of treatment-related adverse events for azithromycin and amoxicillin/clavulanate were 16.8% and 22.5%, respectively. Corresponding rates of diarrhea were 6.4% and 12.7%, respectively. Vomiting, which was generally mild, occurred in 7 children in each group. One azithromycinpatient and 5 amoxicillin/clavulanatepatients discontinued treatment because of adverse events. The compliance rate for azithromycin was significantly higher than that for amoxicillin/clavulanate (99% vs 83%; P<0.001). CONCLUSIONS: In this trial comparing the efficacy of single-dose azithromycin (30 mg/kg) with twice-daily amoxicillin/clavulanate (45 mg/kg) for the treatment of new-onset, uncomplicated AOM, no differences were detected between the 2 regimens. Single-dose azithromycin was generally well tolerated and provides an alternative to conventional oral regimens for AOM.
Authors: M E Pichichero; S McLinn; G Aronovitz; R Fiddes; J Blumer; K Nelson; B Dashefsky Journal: Pediatr Infect Dis J Date: 1997-05 Impact factor: 2.129
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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: Adriano Arguedas; Cecilia Loaiza; Alexandra Perez; Alvaro Gutierrez; Marco Luis Herrera; Constance D Rothermel Journal: Curr Ther Res Clin Exp Date: 2003