STREPTOCOCCUS VIRIDANS

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.

Table of Contents

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]

Trial ID Phase Condition studied Status Enrollment
2025-524212-11-00 Phase 3 Respiratory Tract Infections Authorised 224

Ongoing Clinical Trials on STREPTOCOCCUS VIRIDANS

  • A study to evaluate the effectiveness of a drug combination in reducing respiratory tract infections in children aged 3 to 12 years.

    Not yet recruiting

    1 1 1
    Investigated diseases:
    Poland

Glossary

  • Respiratory tract infections: Infections that affect the nose, throat, airways, or lungs. In this trial, researchers are counting how often these infections happen.
  • Phase 3: A later stage of clinical research. It usually studies how well a treatment works in a larger group of people.
  • Interventional study: A study where researchers give a treatment or placebo and then compare the results.
  • Placebo: A look-alike treatment with no active study drug. It helps researchers compare results fairly.
  • Sublingual use: Taken under the tongue, where it dissolves or is held for absorption.
  • Enrollment: The number of people planned for the trial. Here, 224 children are planned.
  • Primary outcome: The main result researchers measure to see if the study treatment works.
  • Follow-up: The time after treatment when researchers keep checking what happens.

References

  1. https://clinicaltrials.gov/study/2025-524212-11-00