Table of contents
- Trial overview
- Who can join the studies
- What is being measured
- Study design and phases
- Key trial details
- What the available data show
Trial overview
The available trials investigate Staphylococcus Aureus in studies aimed at preventing repeated respiratory infections.[1][2] One study focuses on recurrent lower respiratory tract infections in adults, and the other focuses on respiratory tract infections in children aged 3 to 12 years.[1][2]
Both studies are designed to compare a study product with placebo, which is an inactive comparison treatment used to help show whether the study product has a real effect.[1][2]
Who can join the studies
One trial includes adults with recurrent lower respiratory tract infections.[1] The other trial includes children aged 3 to 12 years with respiratory tract infections.[2]
Adult study population: people with repeated infections in the lower part of the breathing system, such as the airways and lungs.[1]
Children’s study population: boys and girls between 3 and 12 years old who have respiratory tract infections.[2]
What is being measured
The main outcome in the adult study is the reduction in the number of infection episodes during a 12-month treatment period.[1] This means the researchers want to see whether the study product lowers how often infections happen.
The main outcome in the children’s study is the rate of respiratory tract infections, measured by the number of infections each participant has during the study.[2] The observation period includes 3 months of treatment and 4 months of follow-up.[2]
Infection episode: one separate event of illness counted by the researchers.[1]
Follow-up period: the time after treatment when researchers keep checking participants to see what happens next.[2]
Study design and phases
Both trials are interventional, which means the researchers give a study treatment and then measure the results.[1][2] Both are Phase 3 studies, which are later-stage trials done in larger groups to confirm benefit and collect more safety and efficacy data.[1][2]
The adult study is described as randomized, double blind, placebo controlled, and multicenter.[1] Randomized means participants are assigned by chance, double blind means neither the participants nor the study team know who gets which treatment, placebo controlled means the study product is compared with an inactive treatment, and multicenter means the study is run at more than one site.[1]
The children’s study also compares the study product with placebo, but the provided data do not describe it as randomized or double blind.[2]
Key trial details
The adult study, NCT06736288, is authorised and plans to enroll 240 participants.[1] It studies prevention of recurrent lower respiratory tract infections over a 12-month treatment period.[1]
The children’s study, 2025-524212-11-00, is also authorised and plans to enroll 224 participants.[2] It studies whether PMBL (Ismigen) can reduce respiratory infections in children aged 3 to 12 years during a 3-month treatment period and a 4-month follow-up.[2]
NCT06736288: adult study, Phase 3, 240 planned participants, recurrent lower respiratory tract infections, placebo comparison.[1]
2025-524212-11-00: children’s study, Phase 3, 224 planned participants, respiratory tract infections, placebo comparison.[2]
What the available data show
From the trial data provided, the main goal is to see whether the study products can reduce how often respiratory infections happen.[1][2] The studies are still focused on prevention, not on treating a single active infection episode.[1][2]
These trials are important because they study different age groups and different infection patterns, including repeated lower respiratory infections in adults and respiratory infections in children.[1][2]
