Abstract
This article presents data of multicenter open-label randomized clinical trial of clinical and microbiological efficacy and safety of 7- and 10-day courses of new formulation («Solutab») of josamycin in the treatment of acute streptococcal tonsillopharyngitis (AST) in children aged 5-16 years. Clinical symptoms of AST and safety were evaluated during treatment (Day 1 (Randomization), Days 3–5, Day 8, Day 11) and follow-up periods (Days 24–26). Microbiological efficacy was assessed at the end of therapy and on Days 24–26. Both regimens showed high clinical (94.8% for 7 days and 96.4% for 10 days, p>0,05) and microbiological (92.6% and 93.3% respectively, p>0.05) efficacy. All isolated S. pyogenes strains were susceptible to josamycin, MIC50/MIC90 were 0.125 µg/mL. Frequency of adverse events was low: 9.0% in 7-day group and 3.5% in 10-day group with gastrointestinal AE being the most prevalent.
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