[Efficacy and safety of bacterial lysate OM-85 in the treatment of uncomplicated acute respiratory infections: a double-blind, placebo-controlled, multicenter, randomized trial].

To evaluate the efficacy and safety of OM-85 in the treatment of uncomplicated acute respiratory infections (ARI) in adults. A double-blind, placebo-controlled, multicenter, randomized trial included 556 patients (18-60 years old) with mild and moderate ARI and negative results of polymerase chain reaction analysis for SARS-CoV-2 RNA and rapid test for influenza A and B viruses. Patients were randomized into two groups: in the first group ( The superiority of OM-85 over placebo by primary endpoint was observed on the 5th, 7th and 10th days of treatment. OM-85 efficacy has also been proven by secondary criteria. OM-85 shortened the time until the symptoms of ARI resolved according to the WURSS-21 and CCQ, increased the proportion of patients with body temperature below 37°C by 2-9 days. The time needed to resolve the symptoms of disease in 20% of patients according to WURSS-21 was 7 and 9 days in patients taking OM-85 and placebo, respectively. Bacterial lysate increased the probability of complete disappearance of symptoms according to CCQ by 45.7% compared to placebo. The analysis of the frequency and severity of adverse events, laboratory tests, physical and instrumental examination results during treatment confirmed the good tolerability and safety of OM-85. The study confirmed the efficacy and safety of OM-85 in the complex treatment of ARI in adults. Цель. Оценить эффективность и безопасность бактериального лизата ОM-85 в терапии неосложненных острых респираторных инфекций (ОРИ) у взрослых. Материалы и методы. В двойное слепое плацебо-контролируемое многоцентровое рандомизированное исследование включили 556 пациентов (18–60 лет) с легкими и среднетяжелыми ОРИ и отрицательными результатами анализа методом полимеразной цепной реакции на наличие РНК SARS-CoV-2 и экспресс-теста на вирусы гриппа А и В. Больных рандомизировали в две группы: в 1-й (