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Prevention study for Respiratory Tract Infections (RTI)
Official title Prevention With Ismigen of RTIs in Kids
ClinicalTrials.gov ID: NCT07578012
What this study is testing
What is Bacterial Lysates?
Bacterial Lysates is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for respiratory tract infections (rti).
Also referred to as PMBL® sublingual tablet, ISMIGEN®.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Although the efficacy of PMBL® sublingual tablets is evident to most prescribers, the clinical studies available to demonstrate the efficacy of this bacterial lysate in preventing recurrent respiratory tract infections have undeniable methodological biases. To demonstrate the efficacy of PMBL® in the pediatric population without questionable bias, a randomized double-blind Placebo-controlled study will be conducted: one arm of children presenting with a risk of recurrent respiratory tract infections will be treated with PMBL® for a 3-month period, 10 days per months during the fall-winter whereas subjects of the Placebo arm will receive sublingual tablet indistinguishable from PMBL® but without active ingredients.
- Phase 4: studies an already-approved treatment
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 3 to 12. Healthy volunteers may be eligible.
You may be able to join if
- Children of both genders aged from 3 to 12 years.
- Written informed consent obtained from the parents/legally authorized representatives
- Written assent obtained from the subject from 7 years
- Subject presenting with a susceptibility to respiratory tract infections according to the investigator
- No respiratory tract infection within 15 days before the randomization visit
You likely can't join if
- Subject treated with bacterial lysates within the previous 6 months prior to V1 or ongoing treatment.
- Body temperature ≥ 37.5°C at the randomization visit.
- Pregnant/Lactating female or with sexual activity without hormonal contraception, intrauterine device or barrier methods.
- Primary or secondary immunodeficiency, cystic fibrosis, bronchiectasis, alpha-1 antitrypsin deficiency, malignancy, endocrinological diseases or...
- Known sensitivity to the components of study medication.
- Any major surgery within the last 3 months prior to study enrolment or planned to occur within the duration of study.
See the full eligibility criteria
- Children of both genders aged from 3 to 12 years.
- Written informed consent obtained from the parents/legally authorized representatives
- Written assent obtained from the subject from 7 years
- Subject presenting with a susceptibility to respiratory tract infections according to the investigator
- No respiratory tract infection within 15 days before the randomization visit
- All girls of childbearing potential have a negative pregnancy urine testing at randomization visit and are informed and their parents as well of the requirement for contraception during the study.
- A cooperative attitude and ability to correct use of PMBL® tablet.
- Subject treated with bacterial lysates within the previous 6 months prior to V1 or ongoing treatment.
- Body temperature ≥ 37.5°C at the randomization visit.
- Pregnant/Lactating female or with sexual activity without hormonal contraception, intrauterine device or barrier methods.
- Primary or secondary immunodeficiency, cystic fibrosis, bronchiectasis, alpha-1 antitrypsin deficiency, malignancy, endocrinological diseases or other chronic respiratory diseases, except asthma and allergic rhinitis.
- Known sensitivity to the components of study medication.
- Any major surgery within the last 3 months prior to study enrolment or planned to occur within the duration of study.
- Treatment with the following medications:
- Injection or oral administration of steroids within 4 weeks prior to study enrolment.
- Previous and/or concomitant immunosuppressants, immunostimulants, allergen-immunotherapy or gamma globulins within 6 months prior to study enrolment.
- Inability to understand or comply with study procedures or with study treatment intake.
- Subject participating in another treatment clinical study at the time of screening visit.
The study team makes the final eligibility decision.
Where it's taking place
- Bialystok, Poland
- Bydgoszcz, Poland
- Krakow, Poland
- Lublin, Poland
- Oświęcim, Poland
- Poznan, Poland
- Tarnów, Poland
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 3 years to 12 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bialystok, Poland; Bydgoszcz, Poland; Krakow, Poland; Lublin, Poland; Oświęcim, Poland; Poznan, Poland and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.