Table of Contents
- Trial overview
- Who can participate
- What is being tested
- Study phase and design
- Outcomes being measured
- Trial status and size
Trial overview
One authorised interventional study is listed for STREPTOCOCCUS PYOGENES, and it focuses on reducing respiratory infections in children.[1] The study title says it is designed to show the efficacy of PMBL (Ismigen) in lowering respiratory infections in children aged 3 to 12 years.[1]
Who can participate
The target population is children aged 3 to 12 years.[1] The study is aimed at children with respiratory tract infections, which are infections that affect the airways and lungs.[1]
What is being tested
The trial compares PMBL (Ismigen) tablets with placebo, which is an inactive treatment used for comparison.[1] The tablets are given by sublingual use, meaning they are used under the tongue.[1] The main question is whether PMBL (Ismigen) can reduce the number of respiratory tract infections over the study period.[1]
Study phase and design
This is a Phase 3 trial.[1] Phase 3 studies usually test how well a treatment works in a larger group of people, and this study is planned as an interventional comparison between active treatment and placebo.[1]
Outcomes being measured
The main outcome is the rate of respiratory tract infections, meaning the number of RTIs a child has during the study.[1] This outcome is measured across a 3-month treatment period and a 4-month follow-up period.[1] The study summary says the goal is to see whether the treatment lowers the incidence of respiratory tract infections during the whole observation period compared with placebo.[1]
Trial status and size
The trial status is Authorised, and the planned enrollment is 224 children.[1] This means the study has permission to run and aims to include 224 participants.[1]
