In short
Clinical trials investigating "Streptococcus Pneumoniae" are looking at whether products made from this organism can help prevent repeated respiratory infections. The studies focus on safety and efficacy in children and adults with recurrent lower or general respiratory tract infections. They compare active treatment with placebo and measure how often infections happen over time.
Key points
- Clinical trials investigating "Streptococcus Pneumoniae" are studying prevention of respiratory infections in both adults and children. One Phase 3 trial looks at recurrent lower respiratory tract infections in adults, while another Phase 3 trial looks at respiratory tract infections in children aged 3 to 12 years. Both studies compare an active product with placebo. The main results measure how many infection episodes happen during the study period. These trials are authorised and are designed to collect more evidence about efficacy and safety.
Overview of the trials
The available studies are interventional trials, which means researchers give a study treatment and compare it with placebo. Both trials are Phase 3 studies, so they are later-stage trials that look at how well the treatment works in larger groups of people.
These trials are focused on preventing or reducing respiratory infections, not on treating a single acute infection episode. The studies are authorised and use placebo comparison to help show whether the active product makes a real difference.
Trial 1: Buccalin for recurrent lower respiratory tract infections
NCT06736288 is a randomized, double blind, placebo controlled, two-arm, multicenter post-authorization efficacy and safety study. It is studying Buccalin tablets in adults with recurrent lower respiratory tract infections (RLRTIs).
This study is designed to confirm and collect more clinical data on prophylaxis, which means prevention, of repeated infections. The trial includes 240 participants and lasts 12 months for the treatment period.
The main outcome is the reduction in the number of infection episodes in the Buccalin group compared with the placebo group. This tells researchers whether the treatment can help people have fewer infections over time.
Trial 2: PMBL (Ismigen) for respiratory tract infections in children
The second study, 2025-524212-11-00, is testing PMBL (Ismigen) in children aged 3 to 12 years. It compares sublingual tablets, which are tablets placed under the tongue, with placebo.
This Phase 3 study aims to show that PMBL can reduce the incidence, meaning the number of new cases, of respiratory tract infections during the whole observation period. The study includes a 3-month treatment period and a 4-month follow-up period, for a total observation window of 7 months.
The trial plans to enroll 224 children and measures the rate of respiratory tract infections experienced by each participant during the study. This helps researchers understand whether the treatment lowers infection frequency in children during the fall and winter period.
What the trials measure
The main results, called primary outcomes, focus on how often infections happen in each study group. In the adult study, the outcome is the number of infection episodes over 12 months. In the children’s study, the outcome is the number of respiratory tract infections during treatment and follow-up.
Because both trials compare an active product with placebo, the researchers can judge whether any change in infection rates is likely due to the study treatment. This type of design is important when studying prevention strategies for repeated infections.
Key points for patients
- These studies are about preventing repeated breathing infections, not about treating one short illness episode.
- One study focuses on adults with recurrent lower respiratory tract infections, while the other focuses on children aged 3 to 12 years with respiratory tract infections.
- Both are Phase 3 studies, which means they are testing effectiveness in larger groups after earlier research has already been done.
- Both studies use placebo comparison, so the active product can be measured against a look-alike treatment with no active study product.
- The main goal in both trials is to see whether infection episodes become less frequent over time.