Comparative Tolerability, Safety and Efficacy of Tablet Formulations of Twice-Daily Clarithromycin 250 mg versus Once-Daily Extended-Release Clarithromycin 500 mg in Pediatric and Adolescent Patients

Abstract

Clarithromycin is widely used to treat respiratory tract and superficial skin infections in pediatric and adult populations. Using clinical endpoints and 7-day therapy, we compared the efficacy of clarithromycin 250 mg tablets given twice daily versus clarithromycin 500 mg extendedrelease tablets given once daily in ambulatory children and adolescents 6 to 16 years old. Of the 199 evaluable patients, 124 were infected with group A streptococcal pharyngitis, 39 with sinusitis, 21 with ambulatory pneumonia, and 15 with superficial skin infections. The overall cure rate exceeded 90% for each treatment group. Discontinuation rates and adverse events were 4.5% and 24.6%, respectively.