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Streptococcus Pneumoniae

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.

Table of Contents

Overview of the trials

The available studies are interventional trials, which means researchers give a study treatment and compare it with placebo.[1][2] 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.[1][2]

These trials are focused on preventing or reducing respiratory infections, not on treating a single acute infection episode.[1][2] The studies are authorised and use placebo comparison to help show whether the active product makes a real difference.[1][2]

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.[1] It is studying Buccalin tablets in adults with recurrent lower respiratory tract infections (RLRTIs).[1]

This study is designed to confirm and collect more clinical data on prophylaxis, which means prevention, of repeated infections.[1] The trial includes 240 participants and lasts 12 months for the treatment period.[1]

The main outcome is the reduction in the number of infection episodes in the Buccalin group compared with the placebo group.[1] This tells researchers whether the treatment can help people have fewer infections over time.[1]

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.[2] It compares sublingual tablets, which are tablets placed under the tongue, with placebo.[2]

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.[2] The study includes a 3-month treatment period and a 4-month follow-up period, for a total observation window of 7 months.[2]

The trial plans to enroll 224 children and measures the rate of respiratory tract infections experienced by each participant during the study.[2] This helps researchers understand whether the treatment lowers infection frequency in children during the fall and winter period.[2]

What the trials measure

The main results, called primary outcomes, focus on how often infections happen in each study group.[1][2] In the adult study, the outcome is the number of infection episodes over 12 months.[1] In the children’s study, the outcome is the number of respiratory tract infections during treatment and follow-up.[2]

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.[1][2] This type of design is important when studying prevention strategies for repeated infections.[1][2]

Key points for patients

  • These studies are about preventing repeated breathing infections, not about treating one short illness episode.[1][2]

  • 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.[1][2]

  • Both are Phase 3 studies, which means they are testing effectiveness in larger groups after earlier research has already been done.[1][2]

  • Both studies use placebo comparison, so the active product can be measured against a look-alike treatment with no active study product.[1][2]

  • The main goal in both trials is to see whether infection episodes become less frequent over time.[1][2]

Trial ID Phase Condition studied Status Enrollment
NCT06736288 Phase 3 Recurrent lower respiratory tract infections Authorised 240
2025-524212-11-00 Phase 3 Respiratory tract infections in children aged 3 to 12 years Authorised 224

FAQ

  • Who can take part in these clinical trials? The trials shown include adults with recurrent lower respiratory tract infections and children aged 3 to 12 years with respiratory tract infections. Each study has its own rules for who can join.
  • What are the trials trying to find out? They are checking whether the study products can reduce the number of respiratory infection episodes. The studies also collect more clinical data on safety and effectiveness.
  • What phase are these trials in? Both trials are Phase 3 studies. This means they are later-stage studies that test how well a treatment works in larger groups of people.
  • What conditions are being studied? One trial studies recurrent lower respiratory tract infections, and the other studies respiratory tract infections in children. Both focus on infections of the breathing passages and lungs.
  • How are the treatments compared in the trials? Both studies compare an active product with placebo. A placebo looks like the study treatment but does not contain the active product, so researchers can see the real effect of the treatment.

Ongoing Clinical Trials on Streptococcus Pneumoniae

  • Study on Buccalin for Preventing Recurrent Lower Respiratory Infections in Adults

    Recruiting

    1 1 1
    Investigated drugs:
    Italy

  • 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:
    Investigated drugs:
    Poland

Glossary

  • Clinical trial: A research study in people that tests whether a treatment is safe, works well, or both.
  • Phase 3: A later stage of research that studies how well a treatment works and continues to check safety in larger groups.
  • Placebo: A look-alike treatment with no active study product. It helps researchers compare results fairly.
  • Interventional study: A study where researchers give a treatment or placebo and then measure the results.
  • Randomized: Participants are assigned by chance to different study groups, which helps make the comparison fair.
  • Double blind: A study design where neither the participant nor the study team knows who gets the active treatment or placebo.
  • Multicenter: A study carried out at more than one hospital or clinic.
  • Prophylaxis: Prevention of a disease or medical problem before it happens.
  • Recurrent: Something that keeps coming back again and again.
  • Respiratory tract infections: Infections that affect the breathing passages, such as the nose, throat, airways, or lungs.
  • Lower respiratory tract infections: Infections that affect the lower airways and lungs.
  • Primary outcome: The main result the researchers measure to see if the study treatment works.

References