Treatment of influenza and other acute respiratory viral infections in children: multicenter double-blind placebo-controlled randomized comparative clinical trial

Abstract

The article presents the main results of a randomized clinical trial of the efficacy and safety of Panavir®, rectal suppositories 100 μg, in children with influenza and other acute respiratory viral infections (ARVI).Characteristics of children and research methods. The trial included 40 children from 12 to 17 years old, the children were randomized into 2 groups: 20 children were treated with Panavir®, 1 rectal suppository per day for 7days, 20 children received placebo according to Panavir® regimen on the background of standard symptomatic therapy. The scientists monitored the efficacy criteria: the primary criteria: recovery time and the number of patients with successful treatment (normalization of axillary body temperature no later than 48 hours of therapy); the main secondary criteria: the timing of the normalization of body temperature, the disappearance of intoxication and catarrhal symptoms and satisfaction with the results of treatment by the parents /adoptive parents of patients on the IMPSS scale.Results. In the Group of Panavir®, the authors registered shorter mean recovery periods (4.5 days versus 7.4 days in the Group of Placebo), normalization of body temperature (39.1 hours versus 76.1 hours) and regression of intoxication manifestations (2.9 days versus 4.3 days) and catarrhal (3.4 days versus 5.6 days) syndromes (with statistical significance of intergroup differences). The treatment success was achieved in 85% of cases in the Panavir® Group versus 30% of cases in the Placebo Group; according to this criterion Panavir® exceeded placebo by at least 24.7%. At the end of the therapy course, 80% of the parents /adoptive parents were satisfied with the treatment results in the Panavir® Group versus 25% of cases in the Placebo Group. The authors determined a comparable incidence of adverse events in the Panavir® and Placebo Groups. There were no adverse events associated with the administration of Panavir®.Conclusion. This study established the efficacy and safety of Panavir® in the treatment of children of 12-17 years old with influenza and other acute respiratory viral infections. This drug with a combined antiviral and immunomodulatory effect is promising for pediatric practice.