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OM-85 dans les infections pédiatriques récurrentes des voies respiratoires avec respiration sifflante et maladie des voies respiratoires inférieures

24 septembre 2026 mis à jour par: OM Pharma SA

Une étude randomisée, contrôlée par placebo, à 3 bras, en double aveugle, multicentrique, de phase 4 pour évaluer l'efficacité du traitement à court et à long terme OM-85 (Broncho-Vaxom) par rapport au placebo dans la prévention des infections des voies respiratoires chez les enfants âgés de 6 mois à 5 ans atteints d'une maladie des voies respiratoires inférieures sifflante

This study will assess the efficacy and safety of OM-85 compared to placebo in reducing the number of respiratory tract infections (RTIs) in children aged between 6 months and 5 years.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Description détaillée

This is a Phase 4, randomised, double-blind, placebo-controlled study to assess the efficacy and safety of short- and long-term treatment with OM-85.

The study will consist of screening (up to 20 days before randomisation), Treatment period of 12 months, and an Observational period of 6 months.

The subjects will be randomised in a ratio of 1:1:1 ratio to receive either OM-85 for 12 consecutive months (BV-12 arm), or OM-85 for 3 consecutive months followed by matching placebo for 9 consecutive months (BV-3 arm), or placebo for 12 consecutive months (Placebo arm).

The expected duration of subject participation is 18 months (+20 days).

Type d'étude

Interventionnel

Inscription (Réel)

525

Phase

  • Phase 4

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • Allemagne
    • Bavaria
      • München, Bavaria, Allemagne, 80337
        • Ludwig Maximilians Universität München
      • Schönau am Königssee, Bavaria, Allemagne, 83471
        • Clinical Research & Healthcare GmbH
    • Lower Saxony
      • Hanover, Lower Saxony, Allemagne, 30625
        • Medizinische Hochschule Hannover
    • North Rhine-Westphalia
      • Bochum, North Rhine-Westphalia, Allemagne, 44791
        • St. Josef-Hospital
      • Cologne, North Rhine-Westphalia, Allemagne, 50937
        • University Hospital Cologne AöR
      • Düsseldorf, North Rhine-Westphalia, Allemagne, 40217
        • Ev. Krankenhaus Düsseldorf
      • Mönchengladbach, North Rhine-Westphalia, Allemagne, 41236
        • Praxis Köllges
      • Wesel, North Rhine-Westphalia, Allemagne, 46483
        • Marien-Hospital Wesel gGmbH
    • Schleswig-Holstein
      • Lübeck, Schleswig-Holstein, Allemagne, 23538
        • Universitätsklinikum Schleswig-Holstein Campus Lübeck
  • Hongrie
      • Balassagyarmat, Hongrie, H-2660
        • Dr. Kenessey Albert Korhaz-Rendelointezet
      • Budapest, Hongrie, 1089
        • Heim Pal Orszagos Gyermekgyogyaszati Intezet
      • Budapest, Hongrie, 1083
        • Semmelweis Egyetem I.sz. Gyermekgyogyaszati Klinika
      • Gyula, Hongrie, 5700
        • Sanitas Diagnosztikai és Rehabilitációs Központ
      • Miskolc, Hongrie, 3527
        • Futurenest Kft.
    • Csongrád megye
      • Szeged, Csongrád megye, Hongrie, 6720
        • Aranyklinika Kft
  • Italie
      • Bari, Italie, 70126
        • Osp.Pediatr.Giov.XXIII,AOUC P.Bari
      • Bergamo, Italie, 24127
        • ASST Papa GiovanniXXIII,Mat.Inf.Ped
    • Parma
      • Parma, Parma, Italie, 43100
        • Azienda ospedalo universitaria
    • Pavia
      • Pavia, Pavia, Italie, 27100
        • Universita degli Studi di Pavia - Fondazione IRCCS Policlini
    • Pisa
      • Pisa, Pisa, Italie, 56126
        • SO S.Chiara, AOU Pisana
  • Pologne
      • Krakow, Pologne, 31-411
        • Centrum Medyczne PROMED
      • Rzeszów, Pologne, 35-612
        • Podkarpacki Osrodek Pulmonologii i Alergologii Sp. z o.o.
      • Skierniewice, Pologne, 96-100
        • Velocity Skierniewice Sp. z o.o.
      • Warsaw, Pologne, 01-231
        • Przychodnia Specjalistyczna Prosen-Med NZOZ
    • Lesser Poland Voivodeship
      • Krakow, Lesser Poland Voivodeship, Pologne, 31-624
        • Malopolskie Centrum Alergologii
      • Tarnów, Lesser Poland Voivodeship, Pologne, 33-100
        • ALERGO-MED Specjalistyczna Przychodnia Lekarska Spolka z o.o.
    • Lublin Voivodeship
      • Lublin, Lublin Voivodeship, Pologne, 20-552
        • Centrum Alergologii Specjalistyczna Przychodnia Alergologiczna
    • Lódzkie
      • Lodz, Lódzkie, Pologne, 90-329
        • WWCOiT im. M. Kopernika w Lodzi, Osrodek Pediatryczny im. dr J.Korczaka
    • Podlaskie Voivodeship
      • Bialystok, Podlaskie Voivodeship, Pologne, 15-879
        • NZOZ E-Vita
    • Silesian Voivodeship
      • Częstochowa, Silesian Voivodeship, Pologne, 42-217
        • Centrum Medyczne Pratia Czestochowa
      • Siemianowice Śląskie, Silesian Voivodeship, Pologne, 41-103
        • NZLA Michalkowice - Jarosz i Partnerzy Spolka Lekarska
    • Świętokrzyskie Voivodeship
      • Skarżysko-Kamienna, Świętokrzyskie Voivodeship, Pologne, 26-110
        • NSZOZ Puls - Med Anna Bogusz, Agnieszka Musielak Sp.J.
  • Royaume-Uni
      • Edinburgh, Royaume-Uni, EH9 1LF
        • Royal Hospital for Children and Young People
      • London, Royaume-Uni, SE5 9RS
        • King's College Hospital
      • London, Royaume-Uni, E1 4NS
        • Royal London Hospital
    • East Sussex
      • Brighton, East Sussex, Royaume-Uni, BN2 5BE
        • Brighton And Sussex University Hospitals NHS Trust
    • Manchester
      • Manchester, Manchester, Royaume-Uni, M13 9WL
        • Royal Manchester Children's Hospital - Paediatrics - Paediatrics
    • Nottingham
      • Nottingham, Nottingham, Royaume-Uni, NG7 2UH
        • Nottingham University Hospitals NHS Trust - Queen's Medical Centre
  • Suisse
      • Geneva, Suisse, 1205
        • Hôpitaux Universitaires de Genève (HUG)
      • Zurich, Suisse, 8032
        • Universitaets-Kinderklinik - Kinderspital Zuerich
    • Canton of Bern
      • Bern, Canton of Bern, Suisse, 3010
        • Inselspital Bern Kinderklinik
    • Canton of Vaud
      • Lausanne, Canton of Vaud, Suisse, 1011
        • CHUV-Centre Hopitalier Universitaire Vaudois

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

6 mois à 5 ans (Enfant)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

Inclusion Criteria:

  • Children of either gender aged between 6 months and 5 years, at Baseline/Randomisation (Visit 2) inclusive.
  • For children ≥1 year of age, ≥4 RTIs (as reported by parents or LAR of subject), including ≥2 episodes of wLRIs (including ≥1 triggering hospitalisation or medical visit) within 12 months prior to enrolment.

OR

  • For children <1 year of age, ≥2 RTIs (as reported by parents or LAR of subject), including ≥1 episode of wLRIs (including ≥1 triggering hospitalisation or medical visit) within 6 months prior to enrolment.
  • Parents or LAR of subject have provided the appropriate written informed consent. Written informed consent must be provided before any study-specific procedures are performed including screening procedures.

Exclusion Criteria:

  • Anatomic alterations of the respiratory tract.

  • Other chronic respiratory diseases (e.g., tuberculosis, cystic fibrosis).

  • Any autoimmune disease.

  • HIV infection or any type of congenital or iatrogenic immune deficiency (including IgA deficiency).

  • Known severe congenital heart disease.

  • Haematologic diseases.

  • Liver or kidney failure.

  • New-borns before 34 weeks of gestational age.

  • Malnutrition as per World Health Organization (WHO) definition.

  • Any known neoplasia or malignancy.

  • Treatment with the following medications:

    1. Injection or oral administration of steroids within 4 weeks prior to study enrolment.
    2. Previous and/or concomitant immunosuppressants, immunostimulants, or gamma globulins within 6 months prior to study enrolment.

  • Previous use within last 6 months of enrolment or ongoing use of bacterial lysates.

  • Any major surgery within the last 3 months prior to study enrolment.

  • Known allergy or previous intolerance to investigational medicinal products (IMP).

  • Any other clinical conditions, that in the opinion of the Investigator, would not allow safe completion of the clinical study.

  • Other household members have previously been randomised in this clinical study.

  • Subjects' families expected to relocate out of study area within 24 months of the initiation of the study.

  • Currently enrolled in or has completed any other investigational device or drug study or receiving other investigational agent(s) within <30 days prior to screening.

  • Parents or legally acceptable representative (LAR) who do not have access to internet connection.

  • Wheezing documented to be caused by gastroesophageal reflux.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Double

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: BV-12

Subjects will receive OM-85 treatment for 12 consecutive months. (10 days per month)
Médicament: OM-85

Subjects will be administered OM-85 3.5 mg capsules by mouth once daily. (10 days per month)
Expérimental: BV-3

Subjects will receive OM-85 treatment for 3 consecutive months, followed by matching placebo for 9 consecutive months. (10 days per month)
Médicament: OM-85

Subjects will be administered OM-85 3.5 mg capsules by mouth once daily. (10 days per month)
Comparateur placebo: Placebo

Subjects will receive matching placebo for 12 consecutive months. (10 days per month)
Médicament: Placebo

Subjects will be administered Placebo once daily. (10 days per month)

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Rate of respiratory tract infections (RTIs)
Délai: 12 Months

The number of RTIs experienced by a subject during the Treatment period will be assessed.
12 Months

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Rate of wheezing lower respiratory infections (wLRIs) experienced by a subject
Délai: 12 Months

The number of wLRIs experienced by a subject during the Treatment period will be assessed. This is the key secondary endpoint
12 Months
Rate of wLRIs
Délai: 18 Months

The number of wLRIs experienced by a subject during the Treatment period, during the Observational period, and during the whole study period will be assessed.
18 Months
Rate of respiratory tract infections (RTIs)
Délai: 18 Months

The number of RTIs experienced by a subject during the Treatment period, during the Observational period, and during the whole study period will be assessed.
18 Months
Proportion of subjects with recurrent RTIs
Délai: 18 Months

The proportion of subjects experiencing ≥3 RTIs during the first 6 months of Treatment period, the proportion of subjects experiencing ≥4 RTIs during the full 12-month Treatment period and the proportion of subjects experiencing ≥6 RTIs during the full 12-month Treatment period and during the whole study period will be assessed.
18 Months
Proportion of subjects with wLRIs
Délai: 18 Months

The proportion of subjects with wLRIs during the Treatment period, during the Observational period, and during the whole study period will be assessed.
18 Months
Rate of severe wheezing lower respiratory illness (SwLRIs)
Délai: 18 Months

The number of SwLRIs experienced by a subject during the Treatment period, during the Observational period, and during the whole study period will be assessed.
18 Months
Proportion of subjects with SwLRIs
Délai: 18 Months

The proportion of subjects with SwLRIs during the Treatment period, during the Observational period, and during the whole study period will be assessed.
18 Months
Time to first, second and third RTI and wLRI
Délai: 18 Months

Time to first, second and third RTI and wLRI during the whole study period will be assessed.
18 Months
Mean duration in days per RTI and acute RTI
Délai: 18 Months

Mean duration in days per RTI and mean duration in days per acute RTI during the Treatment period, during the Observational period, and during the whole study period will be assessed.
18 Months
Mean duration in days per wLRI
Délai: 18 Months

Mean duration in days per wLRI during the Treatment period, during the Observational period, and during the whole study period will be assessed.
18 Months
Mean duration in days per SwLRI
Délai: 18 months

Mean duration in days per SwLRI during the Treatment period, during the Observational period, and during the whole study period will be assessed.
18 months
Number of healthcare resource utilisations
Délai: 18 Months

Number of healthcare resource utilisations (inpatient hospitalisations, visits to emergency rooms, or to a physician/health care provider) due to an RTI and/or a wLRI during the Treatment period, during the Observational period, and during the whole study period will be assessed.
18 Months
Number of absent days from daycare
Délai: 18 Months

Number of absent days from daycare due to an RTI and/or a wLRI during the Treatment period, during the Observational period, and during the whole study period will be assessed.
18 Months
Number of antibiotic treatments for a respiratory event
Délai: 18 Months

Number of antibiotic treatments for a respiratory event during the Treatment period, during the Observational period, and during the whole study period will be assessed.
18 Months
Duration of antibiotic treatments for a respiratory event
Délai: 18 Months

Duration of antibiotic treatments for a respiratory event during the Treatment period, during the Observational period, and during the whole study period will be assessed.
18 Months
Number of systemic corticosteroids, inhaled corticosteroids (ICS) and β2-agonist treatments for a wLRI
Délai: 18 Months

Number of systemic corticosteroids, ICS and β2-agonist treatments for a wLRI during the Treatment period, during the Observational period, and during the whole study period will be assessed.
18 Months
Duration of systemic corticosteroids, ICS and β2-agonist treatments for a wLRI
Délai: 18 Months

Duration of systemic corticosteroids, ICS and β2-agonist treatments for a wLRI during the Treatment period, during the Observational period, and during the whole study period will be assessed.
18 Months
Symptom duration as per the adapted Wisconsin Upper Respiratory Symptom Survey for Kids (WURSS-K) questionnaire
Délai: 18 Months

Symptom duration during the Treatment period, during the Observational period, and during the whole study period will be assessed using WURSS-K questionnaire. Adapted WURSS-K is a valid and reliable illness-specific quality of life instrument that evaluates the impacts of RTIs on children.
18 Months
Symptom types as per the adapted WURSS-K questionnaire
Délai: 18 Months

Symptom types during the Treatment period, during the Observational period, and during the whole study period will be assessed using WURSS-K questionnaire. Adapted WURSS is a valid and reliable illness-specific quality of life instrument that evaluates the impacts of RTIs on children.
18 Months
Symptom severity as per the adapted WURSS-K questionnaire
Délai: 18 Months

Symptom severity during the Treatment period, during the Observational period, and during the whole study period will be assessed using WURSS-K questionnaire. Adapted WURSS is a valid and reliable illness-specific quality of life instrument that evaluates the impacts of RTIs on children.
18 Months
Proportion of subjects who have not used antibiotics as rescue medication for RTI
Délai: 18 Months

The proportion of subjects who have not used antibiotics as rescue medication for RTI during the Treatment period, during the Observational period, and during the whole study period will be assessed.
18 Months
Proportion of subjects who have not been hospitalised for an RTI
Délai: 18 Months

The proportion of subjects who have not been hospitalised for an RTI during the Treatment period, during the Observational period, and during the whole study period will be assessed.
18 Months
Proportion of subjects who have not been administered a systemic corticosteroid for wLRI
Délai: 18 Months

The proportion of subjects who have not been administered a systemic corticosteroid for wLRI during the Treatment period, during the Observational period, and during the whole study period will be assessed.
18 Months
Proportion of subjects who have not been hospitalised for more than 1 day for wLRI
Délai: 18 Months

The proportion of subjects who have not been hospitalised for more than 1 day for wLRI during the Treatment period, during the Observational period, and during the whole study period will be assessed.
18 Months

Autres mesures de résultats

Mesure des résultats
Description de la mesure
Délai
Number of subjects with adverse events and serious adverse event
Délai: 18 Months

The safety of short- and long-term treatment with OM-85 vs. placebo in children aged between 6 months and 5 years with recurrent RTIs associated with wLRI during the Treatment period and during the Observational period will be assessed.
18 Months

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

OM Pharma SA

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

12 décembre 2022

Achèvement primaire (Réel)

10 mars 2026

Achèvement de l'étude (Réel)

16 septembre 2026

Dates d'inscription aux études

Première soumission

14 décembre 2022

Première soumission répondant aux critères de contrôle qualité

22 décembre 2022

Première publication (Réel)

10 janvier 2023

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

25 septembre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

24 septembre 2026

Dernière vérification

1 septembre 2026

Plus d'information

Termes liés à cette étude

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • BV-2020/08
  • 2024-511581-37-00 (Ctis)

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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