In short
Clinical trials investigating STREPTOCOCCUS PYOGENES are studying a treatment called PMBL (Ismigen) in children with respiratory tract infections. The main goal is to see whether it can reduce the number of infections compared with placebo. The trial is in children aged 3 to 12 years.
Key points
- One clinical trial is listed for STREPTOCOCCUS PYOGENES. It is a Phase 3 interventional study in children aged 3 to 12 years with respiratory tract infections. The study compares PMBL (Ismigen) with placebo. The main goal is to see whether treatment lowers the number of respiratory tract infections during a 3-month treatment period and a 4-month follow-up. The trial is authorised and plans to enroll 224 children.
Trial overview
One authorised interventional study is listed for STREPTOCOCCUS PYOGENES, and it focuses on reducing respiratory infections in children. 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.
Who can participate
The target population is children aged 3 to 12 years. The study is aimed at children with respiratory tract infections, which are infections that affect the airways and lungs.
What is being tested
The trial compares PMBL (Ismigen) tablets with placebo, which is an inactive treatment used for comparison. The tablets are given by sublingual use, meaning they are used under the tongue. The main question is whether PMBL (Ismigen) can reduce the number of respiratory tract infections over the study period.
Study phase and design
This is a Phase 3 trial. 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.
Outcomes being measured
The main outcome is the rate of respiratory tract infections, meaning the number of RTIs a child has during the study. This outcome is measured across a 3-month treatment period and a 4-month follow-up period. 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.
Trial status and size
The trial status is Authorised, and the planned enrollment is 224 children. This means the study has permission to run and aims to include 224 participants.