In short
Clinical trials investigating "STREPTOCOCCUS VIRIDANS" are studying whether a related study treatment can reduce respiratory infections in children. The trials focus on safety and effectiveness in children aged 3 to 12 years, mainly during the fall and winter period.
Key points
- Clinical trials investigating "STREPTOCOCCUS VIRIDANS" are focused on respiratory tract infections in children. The main study is a Phase 3 interventional trial in children aged 3 to 12 years. It compares a study treatment with placebo during a 3-month treatment period and a 4-month follow-up. The main outcome is the number of respiratory tract infections each child has during the whole study period. The trial is authorised and plans to enroll 224 participants.
Trial overview
This clinical trial is a Phase 3 study of STREPTOCOCCUS VIRIDANS-related research in children with respiratory tract infections. 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.
Who can participate
The target population is children aged 3 to 12 years. The source data does not give more detailed entry rules, so the main known eligibility feature is age.
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. It compares a study treatment with placebo, which is a look-alike treatment used for comparison.
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.
Study design and phase
This is an interventional study, which means researchers give a study treatment and then measure the results. The study is in Phase 3, so it is testing the treatment in a later stage and in a larger group of participants.
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.
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. Researchers measure this across a 3-month treatment period and a 4-month follow-up period.
This endpoint is important because it shows whether the study treatment may reduce how often children get these infections over time.
Study status and enrollment
The trial status is Authorised, which means it has been approved to proceed in the source record. The planned enrollment is 224 children.
Only one trial record was provided, so this article focuses on that study and its main research question.