In short
Klebsiella pneumoniae is a type of bacteria that can cause serious infections, but it is also one of several bacterial strains used to make a medicine called a bacterial lysate. This lysate is authorised as a medicine and is being studied in a Phase 3 trial to see if it reduces respiratory tract infections in children aged 3 to 12 years. The trial, which plans to enrol 224 participants, compares the sublingual tablet against a placebo.
Key points
- Klebsiella pneumoniae is a bacterium that can cause pneumonia and other infections, but is also used in a medicine called a bacterial lysate.
- The medicine is authorised and sold under the brand name Ismigen as a sublingual tablet.
- A Phase 3 trial is testing the lysate in 224 children aged 3 to 12 years with respiratory tract infections.
- The trial compares the Ismigen sublingual tablet against a placebo.
- The main measure is the rate of respiratory tract infections over a 3-month treatment and 4-month follow-up period.
- The trial is currently authorised, meaning it can begin recruiting participants.
What is klebsiella pneumoniae?
Klebsiella pneumoniae is a type of bacteria commonly found in the human gut and respiratory tract. It can also live in soil and water. While often harmless, some strains can cause infections such as pneumonia, urinary tract infections, wound infections, and meningitis. In the context of the medicine described here, klebsiella pneumoniae is one of several inactivated bacterial strains contained in a bacterial lysate. This lysate is authorised as a medicine under the brand name Ismigen and is classified as a sublingual tablet. Other names for the same active substance combination include Luivac and Paspat.
How does klebsiella pneumoniae work?
As a bacterial lysate, the medicine contains fragments of inactivated bacteria, including Klebsiella pneumoniae, Haemophilus influenzae, Staphylococcus aureus, and several Streptococcus species. The idea behind a bacterial lysate is that exposing the immune system to these bacterial fragments, without causing a full infection, helps train the body's defences. This is intended to reduce the frequency of respiratory tract infections. The exact way this happens is still being studied, but the goal is to stimulate a protective immune response.
Which conditions is it used or studied for?
- Respiratory tract infections (RTIs) — The authorised medicine is used to help prevent recurrent respiratory infections. The current Phase 3 trial is specifically testing whether the lysate reduces the number of RTIs in children aged 3 to 12 years during the autumn and winter period.
- Pneumonia — Klebsiella pneumoniae as a live bacterium can cause pneumonia, which is a serious lung infection. However, the medicine containing the bacterial lysate is not used to treat an active Klebsiella infection; it is used to help prevent respiratory infections in general.
- Urinary tract infections — Live klebsiella pneumoniae can cause UTIs, but this is a disease caused by the bacterium, not a condition the lysate medicine is used for.
How is klebsiella pneumoniae given?
The medicine is given as a sublingual tablet, which means it is placed under the tongue and allowed to dissolve. The tablet contains 50 mg of the bacterial lysate. The route of administration is sublingual use.
What do the clinical trials show?
There is currently one authorised Phase 3 clinical trial investigating this bacterial lysate. The trial is designed to test whether the medicine, when used according to the product information during the autumn and winter, can reduce the number of respiratory tract infections in children aged 3 to 12 years compared to a placebo.
The trial plans to enrol 224 participants. Participants will receive either the Ismigen sublingual tablet or a placebo for a 3-month treatment period, followed by a 4-month follow-up. The main measure is the rate of respiratory tract infections, meaning the number of RTIs each child experiences over the entire 7-month observation period.
The trial status is authorised, meaning it has received regulatory approval to begin, but results are not yet available.
What side effects are known?
The supplementary sources provided do not list specific side effects for the bacterial lysate medicine. Therefore, no side effect information is included here.