Table of Contents
- Trial overview
- Who can participate
- What is being studied
- Study design and phase
- Endpoints and what researchers measure
- Study status and enrollment
Trial overview
This clinical trial is a Phase 3 study of STREPTOCOCCUS VIRIDANS-related research in children with respiratory tract infections.[1] The study is titled as a trial to show the efficacy of PMBL (Ismigen) in reducing 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 source data does not give more detailed entry rules, so the main known eligibility feature is age.[1]
What is being studied
The study is looking at whether the treatment can reduce the number of respiratory tract infections during the whole observation period.[1] It compares a study treatment with placebo, which is a look-alike treatment used for comparison.[1]
The brief summary says the treatment is used during the fall and winter period, and the goal is to lower the incidence of respiratory tract infections compared with placebo.[1]
Study design and phase
This is an interventional study, which means researchers give a study treatment and then measure the results.[1] The study is in Phase 3, so it is testing the treatment in a later stage and in a larger group of participants.[1]
The trial uses a placebo comparison and includes a treatment period followed by follow-up, allowing researchers to see both short-term and later effects.[1]
Endpoints and what researchers measure
The primary outcome is the rate of respiratory tract infections, meaning the number of infections each child has during the study.[1] Researchers measure this across a 3-month treatment period and a 4-month follow-up period.[1]
This endpoint is important because it shows whether the study treatment may reduce how often children get these infections over time.[1]
Study status and enrollment
The trial status is Authorised, which means it has been approved to proceed in the source record.[1] The planned enrollment is 224 children.[1]
Only one trial record was provided, so this article focuses on that study and its main research question.[1]



