Respiratory Infections in Children Clinical Trial
Official title:
Multicenter Double Blinded Placebo-controlled Randomized Study to Evaluate Clinical Efficacy, Tolerability, Safety of Medical Product Derinat®, Solution for External and Local Use 0.25% in Acute Infections of Respiratory System in Children
This multicenter prospective double blinded placebo-controlled randomized study is designed to to evaluate clinical efficacy, tolerability and safety of medical product Derinat®, solution for external and local use 0.25% in acute infections of respiratory system in children
This is a multi-center, double-blind, randomized phase III-IV clinical trial in parallel
groups to evaluate the efficacy and safety of Derinat versus Placebo in patients with acute
upper respiratory tract infection.
The study will include only patients with mild to moderate acute upper respiratory tract
infection, without complications. According to the recommendations of the FDA (Guidance for
Industry Influenza: Developing Drugs for Treatment and/or Prophylaxis) this category of
patients is the best suited for placebo-controlled studies, because the expected serious
risks without treatment are negligible. For studies evaluating the therapy of patients with
mild to moderate acute respiratory upper respiratory tract infection without complications, a
placebo-controlled trial design is preferred, as opposed to designs with no less efficacy
(non-inferiority).
This study provides for the inclusion of both outpatient patients and patients admitted to
the hospital for epidemiological indications (i.e. patients with acute respiratory infection
of the upper respiratory tract of mild and moderate severity without complications that pose
an epidemic risk.
Assessment of criteria of severity of acute respiratory infection of the upper respiratory
tract will be carried out by Investigator based on standards of diagnosis and treatment of
infectious diseases in children at the stages of medical care, depending on the forms of
severity of the disease.
The study is planned sequentially in 5 age groups. The study begins with the older age group
and as the results on the safety of the drug are obtained, in the course of the study, it is
possible to move to younger age groups
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