Respiratory Tract Infections (RTI)Phase 4PIRTIKNCT07578012
Prevention With Ismigen of RTIs in Kids
A Phase 4 study testing Bacterial Lysates in people with Respiratory Tract Infections (RTI) and Healthy Children, run by Lallemand Pharma AG at 10 sites in Poland.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 3 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Respiratory Tract Infections (RTI), Healthy Children
- What is being tested?
- Bacterial Lysates
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 224 participants
- Where
- 10 sitesPoland
- Study dates
- 1 Jun 2026to Apr 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 11Show fewer
- 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 interventional clinical study at the time of screening visit.
Trial locations and contacts
10 sites in 1 country. Contact the study team or a site near you to ask about taking part.
10 sites in 1 country
Poland10 sites, 10 recruiting
- Recruiting
Bio Zdrowie
Bialystok
- Recruiting
In Vivo Sp. z o.o.
Bydgoszcz
- Recruiting
Vitamed
Bydgoszcz
- Recruiting
Centrum Nowoczesnych Terapii
Krakow
- Not yet recruiting
Comarch Healthcare S.A.
Krakow
- Recruiting
Linden Sp. z o.o. sp.k.
Krakow
- Recruiting
Allergotest
Lublin
- Recruiting
Medicome Sp. z o.o.
Oświęcim
- Recruiting
Med - Polonia
Poznan
- Recruiting
Alergo-Med Specjalistyczna Przychodnia
Tarnów
About this study
Official title: A Randomized Double-blind Placebo-controlled Study to Demonstrate the Efficacy of PMBL® Sublingual Tablets in Reducing the Incidence of Respiratory Tract Infections in Children Aged 3-12 Years (PIRTIK).
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. Both groups of subjects will be followed for four additional months. To improve the accuracy of data and the tracking of respiratory tract infections (RTI), a diary will be provided to each subject, allowing them to report the event as soon as it occurs. If necessary, a visit may be planned to enable the investigator to assess the event accurately.
Read the detailed description
Respiratory tract infections (RTIs) are the leading cause of acute disease incidence worldwide that affect people of all ages. They are usually caused by viral pathogens, the most common of which including rhinoviruses, coronaviruses, adenoviruses, respiratory syncytial virus and influenza viruses. Bacterial pathogens can also cause RTIs, but they are less common. Various studies show the seasonality of RTIs. Influenza tends to occur in late autumn and winter, while other RTIs have a much more diffuse occurrence throughout the year. Although RTIs are usually not life-threatening, they significantly decrease quality of life and represent a substantial proportion of healthcare visits, mainly in women and young children, contributing to a financial burden on society.
Ismigen® (Polyvalent Mechanical Bacterial Lysate; PMBL) which is manufactured by mechanical lysis is currently authorized in two EU Member States (MS), Italy and Poland, where Lallemand Pharma Europe is the Marketing Authorization Holder (MAH) as sublingual tablets for the prophylaxis of recurrent RTI in adults. It is authorized in Poland in children from 3 years of age.
On 27 June 2019, the European Medicines Agency (EMA) recommended that bacterial lysates-containing medicinal products authorized for respiratory conditions should only be used for the prevention of recurrent respiratory tract infections, with the exception of pneumonia. This followed a review in which EMA's human medicines committee (CHMP) considered the results of clinical studies, data on side effects reported with these medicines, and advice from an expert group on infectious diseases. Although data are limited, the review found some evidence of effectiveness of bacterial lysates in the prevention of recurrent RTI together with a safety profile in line with what is expected for this type of product. The CHMP therefore recommended that use of bacterial lysates for prevention can continue, but the companies must provide further data on safety and effectiveness by Q1 2026 through the conduct of phase IV double-blind, multicenter, RCTs in this indication.
The present study is a Post-Authorization Efficacy Study (PAES) designed to demonstrate that PMBL® sublingual tablet used according to the SmPC instructions can reduce the incidence of respiratory tract infections in children 3 to 12 years old during the fall and winter period when compared to a matched Placebo.
- Being tested
- Bacterial Lysates, Placebo
- Keywords
- Respiratory Tract Infections (RTI), Bacterial Lysates, PMBL® sublingual tablets, Recurrent Respiratory Tract Infections, Ismigen, Incidence
- Medical subject headings
- Respiratory Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bacterial LysatesDrug
Also called PMBL® sublingual tablet, ISMIGEN®
3-month period, 10 days per months during the fall-winter
PlaceboDrug
3-month period, 10 days per months during the fall-winter
| Study group | Role | What they receive |
|---|---|---|
| PMBL® sublingual tablet | Active comparator | Ismigen® (Polyvalent Mechanical Bacterial Lysate; PMBL) is a sublingual tablet marketed by Lallemand Pharma Europe. Each tablet contains:
* Lyophilised bacterial lysate 50 mg
* Excipients q.s. 250mg
The posology of Ismigen® for paediatric population (from 3 years of age) is one tablet per day before food, to be dissolved under the tongue. Use for ten consecutive days per month, over a period of 3 months. Receives: Drug: Bacterial Lysates |
| Placebo | Placebo comparator | The comparator is a sublingual tablet, indistinguishable from the investigational product.
Each tablet of placebo comparator has the same composition as the investigational medicinal product being tested (with the exception of the active substance, which is replaced by glycine (7 mg)). Posology, instructions for use, contraindications, precautions of use and labelling are identical to those for Ismigen®.
The posology of Placebo is one tablet per day before food, to be dissolved under the tongue. Use for ten consecutive days per month, over a period of 3 months. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The total number of RTIs experienced by each subject throughout the 7-month study period (3-month treatment + 4-month follow-up).
Rate of Respiratory Tract Infections (RTIs): the number of RTIs experienced by a subject throughout the study (3 month-treatment period and 4 month-follow-up) will be assessed.
Measured: Throughout the 7-month study period (3-month treatment + 4-month follow-up).
Secondary outcomes (7)
Mean duration in days per RTI during the overall study period.
Estimated treatment effect from MMRM with 95% CI.
Measured: Throughout the 7-month study period (3-month treatment + 4-month follow-up).
Number of days with respiratory tract infections during the overall study period
Negative binomial or Poisson regression with 95% CI.
Measured: Throughout the 7-month study period (3-month treatment + 4-month follow-up).
Number of days of antibiotics use during the overall study period
Estimated incidence rate ratio (IRR) using negative binomial regression (or Poisson if appropriate) with 95% CI.
Measured: Throughout the 7-month study period (3-month treatment + 4-month follow-up).
Total number of workdays lost by parents due to their child's respiratory infections during the overall study period.
Total number of workdays lost by children's parents due to the child's respiratory infections during the overall study period (cumulative days) For each endpoint: mean (SD), median (IQR), and cumulative counts by treatment arm; primary between-group effect presented as an incidence rate ratio (IRR) with 95% CI (PMBL® vs placebo). Absolute mean difference and 95% CI will also be provided for interpretability
Measured: Throughout the study (3 month-treatment period and 4 month-follow-up)
Number of physician consultations due to RTI or related complications.
Number of physician consultations due to RTI or related complications during the overall study period (count) For each endpoint: mean (SD), median (IQR), and cumulative counts by treatment arm; primary between-group effect presented as an incidence rate ratio (IRR) with 95% CI (PMBL® vs placebo). Absolute mean difference and 95% CI will also be provided for interpretability
Measured: Throughout the study (3 month-treatment period and 4 month-follow-up)
Number of antibiotic treatments (courses) for a respiratory event during the overall study period.
Number of antibiotic treatments courses for a respiratory event during the overall study period (count of courses) For each endpoint: mean (SD), median (IQR), and cumulative counts by treatment arm; primary between-group effect presented as an incidence rate ratio (IRR) with 95% CI (PMBL® vs placebo). Absolute mean difference and 95% CI will also be provided for interpretability
Measured: Throughout the study (3 month-treatment period and 4 month-follow-up)
Number of subjects with (serious) adverse event and (serious) adverse drug reaction
Descriptive statistics: number and proportion of subjects experiencing events by type and severity Number and type of AEs, SAEs, and SARs during the study period
Measured: Throughout the study (3 month-treatment period and 4 month-follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2026
- Study start1 Jun 2026
- Primary completionMar 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Tract Infections (RTI)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized double-blind Placebo-controlled
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 224 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lallemand Pharma AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Andrzej EMERYK, MD, PhD, Principal investigator, University Children Hospital, Lublin, Poland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07578012
- Sponsor's protocol ID
- LPI-2501
- Other IDs
- 2025-524212-11-00, 2025
- Acronym
- PIRTIK
- Status last verified
- Jul 2026
- First submitted
- 5 May 2026
- Last updated
- 8 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Double-blind Placebo-controlled Study to Demonstrate the Efficacy of PMBL® Sublingual Tablets in Reducing the Incidence of Respiratory Tract Infections in Children Aged 3-12 Years (PIRTIK).
- ClinicalTrials.gov ID
- NCT07578012
- Acronym / sponsor ID
- PIRTIK / LPI-2501
- Keywords
- Respiratory Tract Infections (RTI), Bacterial Lysates, PMBL® sublingual tablets, Recurrent Respiratory Tract Infections, Ismigen, Incidence
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 224 participants (estimated)
- Lead sponsor
- Lallemand Pharma AGIndustry (pharma, biotech, devices)
- Study start
- 1 Jun 2026 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 11 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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. Both groups of subjects will be followed for four additional months. To improve the accuracy of data and the tracking of respiratory tract infections (RTI), a diary will be provided to each subject, allowing them to report the event as soon as it occurs. If necessary, a visit may be planned to enable the investigator to assess the event accurately.
Detailed description
Respiratory tract infections (RTIs) are the leading cause of acute disease incidence worldwide that affect people of all ages. They are usually caused by viral pathogens, the most common of which including rhinoviruses, coronaviruses, adenoviruses, respiratory syncytial virus and influenza viruses. Bacterial pathogens can also cause RTIs, but they are less common. Various studies show the seasonality of RTIs. Influenza tends to occur in late autumn and winter, while other RTIs have a much more diffuse occurrence throughout the year. Although RTIs are usually not life-threatening, they significantly decrease quality of life and represent a substantial proportion of healthcare visits, mainly in women and young children, contributing to a financial burden on society.
Ismigen® (Polyvalent Mechanical Bacterial Lysate; PMBL) which is manufactured by mechanical lysis is currently authorized in two EU Member States (MS), Italy and Poland, where Lallemand Pharma Europe is the Marketing Authorization Holder (MAH) as sublingual tablets for the prophylaxis of recurrent RTI in adults. It is authorized in Poland in children from 3 years of age.
On 27 June 2019, the European Medicines Agency (EMA) recommended that bacterial lysates-containing medicinal products authorized for respiratory conditions should only be used for the prevention of recurrent respiratory tract infections, with the exception of pneumonia. This followed a review in which EMA's human medicines committee (CHMP) considered the results of clinical studies, data on side effects reported with these medicines, and advice from an expert group on infectious diseases. Although data are limited, the review found some evidence of effectiveness of bacterial lysates in the prevention of recurrent RTI together with a safety profile in line with what is expected for this type of product. The CHMP therefore recommended that use of bacterial lysates for prevention can continue, but the companies must provide further data on safety and effectiveness by Q1 2026 through the conduct of phase IV double-blind, multicenter, RCTs in this indication.
The present study is a Post-Authorization Efficacy Study (PAES) designed to demonstrate that PMBL® sublingual tablet used according to the SmPC instructions can reduce the incidence of respiratory tract infections in children 3 to 12 years old during the fall and winter period when compared to a matched Placebo.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Randomized double-blind Placebo-controlled
| Arm | Type | Receives |
|---|---|---|
| PMBL® sublingual tablet | Active comparator | Drug: Bacterial LysatesIsmigen® (Polyvalent Mechanical Bacterial Lysate; PMBL) is a sublingual tablet marketed by Lallemand Pharma Europe. Each tablet contains: * Lyophilised bacterial lysate 50 mg * Excipients q.s. 250mg The posology of Ismigen® for paediatric population (from 3 years of age) is one tablet per day before food, to be dissolved under the tongue. Use for ten consecutive days per month, over a period of 3 months. |
| Placebo | Placebo comparator | Drug: PlaceboThe comparator is a sublingual tablet, indistinguishable from the investigational product. Each tablet of placebo comparator has the same composition as the investigational medicinal product being tested (with the exception of the active substance, which is replaced by glycine (7 mg)). Posology, instructions for use, contraindications, precautions of use and labelling are identical to those for Ismigen®. The posology of Placebo is one tablet per day before food, to be dissolved under the tongue. Use for ten consecutive days per month, over a period of 3 months. |
Who may qualify
- Ages
- 3 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bacterial LysatesAlso: PMBL® sublingual tablet, ISMIGEN®3-month period, 10 days per months during the fall-winter | Drug | PMBL® sublingual tablet |
| Placebo3-month period, 10 days per months during the fall-winter | Drug | Placebo |
Primary outcome
The total number of RTIs experienced by each subject throughout the 7-month study period (3-month treatment + 4-month follow-up).
Time frame: Throughout the 7-month study period (3-month treatment + 4-month follow-up).
Rate of Respiratory Tract Infections (RTIs): the number of RTIs experienced by a subject throughout the study (3 month-treatment period and 4 month-follow-up) will be assessed.
7 secondary outcomes
Mean duration in days per RTI during the overall study period.
Time frame: Throughout the 7-month study period (3-month treatment + 4-month follow-up).
Number of days with respiratory tract infections during the overall study period
Time frame: Throughout the 7-month study period (3-month treatment + 4-month follow-up).
Number of days of antibiotics use during the overall study period
Time frame: Throughout the 7-month study period (3-month treatment + 4-month follow-up).
Total number of workdays lost by parents due to their child's respiratory infections during the overall study period.
Time frame: Throughout the study (3 month-treatment period and 4 month-follow-up)
Number of physician consultations due to RTI or related complications.
Time frame: Throughout the study (3 month-treatment period and 4 month-follow-up)
Number of antibiotic treatments (courses) for a respiratory event during the overall study period.
Time frame: Throughout the study (3 month-treatment period and 4 month-follow-up)
Number of subjects with (serious) adverse event and (serious) adverse drug reaction
Time frame: Throughout the study (3 month-treatment period and 4 month-follow-up)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Andrzej EMERYK, MD, PhD principal investigator
University Children Hospital, Lublin, Poland
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Bacterial Lysates in people with Respiratory Tract Infections (RTI) and Healthy Children, run by Lallemand Pharma AG at 10 sites in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bernard GOUT, PharmD, PhD (+33776583905, bgout@pharmndev.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The total number of RTIs experienced by each subject throughout the 7-month study period (3-month treatment + 4-month follow-up). (time frame: Throughout the 7-month study period (3-month treatment + 4-month follow-up).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2026; AzTrials last refreshed its copy on 7 Nov 2026.