Prevention With Ismigen of RTIs in Kids (PIRTIK)
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).
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Estimado)
Fase
- Fase 4
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Bernard GOUT, PharmD, PhD
- Número de teléfono: +33776583905
- Correo electrónico: bgout@pharmndev.ch
Ubicaciones de estudio
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Bialystok, Polonia
- Reclutamiento
- Bio Zdrowie
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Bydgoszcz, Polonia
- Reclutamiento
- In Vivo Sp. z o.o.
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Bydgoszcz, Polonia
- Reclutamiento
- Vitamed
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Krakow, Polonia
- Reclutamiento
- Centrum Nowoczesnych Terapii
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Krakow, Polonia
- Aún no reclutando
- Comarch Healthcare S.A.
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Krakow, Polonia
- Reclutamiento
- Linden Sp. z o.o. sp.k.
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Lublin, Polonia
- Reclutamiento
- Allergotest
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Oświęcim, Polonia
- Reclutamiento
- Medicome Sp. z o.o.
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Poznan, Polonia
- Reclutamiento
- Med - Polonia
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Tarnów, Polonia
- Reclutamiento
- Alergo-Med Specjalistyczna Przychodnia
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
Acepta Voluntarios Saludables
Descripción
Inclusion 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.
Exclusion Criteria:
- 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 interventional clinical study at the time of screening visit.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Triple
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Comparador activo: PMBL® sublingual tablet
Ismigen® (Polyvalent Mechanical Bacterial Lysate; PMBL) is a sublingual tablet marketed by Lallemand Pharma Europe. Each tablet contains:
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. |
3-month period, 10 days per months during the fall-winter
Otros nombres:
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Comparador de placebos: Placebo
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. |
3-month period, 10 days per months during the fall-winter
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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The total number of RTIs experienced by each subject throughout the 7-month study period (3-month treatment + 4-month follow-up).
Periodo de tiempo: Throughout the 7-month study period (3-month treatment + 4-month follow-up).
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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.
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Throughout the 7-month study period (3-month treatment + 4-month follow-up).
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Mean duration in days per RTI during the overall study period.
Periodo de tiempo: Throughout the 7-month study period (3-month treatment + 4-month follow-up).
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Estimated treatment effect from MMRM with 95% CI.
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Throughout the 7-month study period (3-month treatment + 4-month follow-up).
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Number of days with respiratory tract infections during the overall study period
Periodo de tiempo: Throughout the 7-month study period (3-month treatment + 4-month follow-up).
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Negative binomial or Poisson regression with 95% CI.
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Throughout the 7-month study period (3-month treatment + 4-month follow-up).
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Number of days of antibiotics use during the overall study period
Periodo de tiempo: Throughout the 7-month study period (3-month treatment + 4-month follow-up).
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Estimated incidence rate ratio (IRR) using negative binomial regression (or Poisson if appropriate) with 95% CI.
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Throughout the 7-month study period (3-month treatment + 4-month follow-up).
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Total number of workdays lost by parents due to their child's respiratory infections during the overall study period.
Periodo de tiempo: Throughout the study (3 month-treatment period and 4 month-follow-up)
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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
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Throughout the study (3 month-treatment period and 4 month-follow-up)
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Number of physician consultations due to RTI or related complications.
Periodo de tiempo: Throughout the study (3 month-treatment period and 4 month-follow-up)
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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
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Throughout the study (3 month-treatment period and 4 month-follow-up)
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Number of antibiotic treatments (courses) for a respiratory event during the overall study period.
Periodo de tiempo: Throughout the study (3 month-treatment period and 4 month-follow-up)
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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
|
Throughout the study (3 month-treatment period and 4 month-follow-up)
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Number of subjects with (serious) adverse event and (serious) adverse drug reaction
Periodo de tiempo: Throughout the study (3 month-treatment period and 4 month-follow-up)
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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
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Throughout the study (3 month-treatment period and 4 month-follow-up)
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Andrzej EMERYK, MD, PhD, University Children Hospital, Lublin, Poland
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- LPI-2501
- 2025-524212-11-00 (Ctis)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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