OM-85 in Paediatric Recurrent Respiratory Tract Infections With Wheezing Lower Respiratory Illness

NCT05677763 | Active Not Recruiting Phase 4 DMC

• 2 other identifiers: BV-2020/082024-511581-37-00
• Study Type: interventional
• Target: 525
• Locations: 6 countries
• Sites: 42

Brief Summary

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.

Conditions

Respiratory Tract Infections; Wheezing Lower Respiratory Illness

Outcome Measures

Primary Outcomes (1)

• Rate of respiratory tract infections (RTIs)

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

  12 Months

Secondary Outcomes (23)

• Rate of wheezing lower respiratory infections (wLRIs) experienced by a subject

  12 Months

• Rate of wLRIs

  18 Months

• Rate of respiratory tract infections (RTIs)

  18 Months

• Proportion of subjects with recurrent RTIs

  12 Months

• Proportion of subjects with wLRIs

  18 Months

Other Outcomes (1)

• Number of subjects with adverse events and serious adverse event

  18 Months

Study Arms (3)

BV-12

EXPERIMENTAL

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

Drug: OM-85

BV-3

EXPERIMENTAL

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

Drug: OM-85

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

OM-85 DRUG

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

BV-12; BV-3

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 6 Months - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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:
• Injection or oral administration of steroids within 4 weeks prior to study enrolment.
• 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.

Sponsors & Collaborators

• OM Pharma SA: lead

Study Sites (42)

Ludwig Maximilians Universität München

München, Bavaria, 80337, Germany

Location

Clinical Research & Healthcare GmbH

Schönau am Königssee, Bavaria, 83471, Germany

Location

Medizinische Hochschule Hannover

Hanover, Lower Saxony, 30625, Germany

Location

St. Josef-Hospital

Bochum, North Rhine-Westphalia, 44791, Germany

Location

University Hospital Cologne AöR

Cologne, North Rhine-Westphalia, 50937, Germany

Location

Ev. Krankenhaus Düsseldorf

Düsseldorf, North Rhine-Westphalia, 40217, Germany

Location

Praxis Köllges

Mönchengladbach, North Rhine-Westphalia, 41236, Germany

Location

Marien-Hospital Wesel gGmbH

Wesel, North Rhine-Westphalia, 46483, Germany

Location

Universitätsklinikum Schleswig-Holstein Campus Lübeck

Lübeck, Schleswig-Holstein, 23538, Germany

Location

Aranyklinika Kft

Szeged, Csongrád megye, 6720, Hungary

Location

Dr. Kenessey Albert Korhaz-Rendelointezet

Balassagyarmat, H-2660, Hungary

Location

Semmelweis Egyetem I.sz. Gyermekgyogyaszati Klinika

Budapest, 1083, Hungary

Location

Heim Pal Orszagos Gyermekgyogyaszati Intezet

Budapest, 1089, Hungary

Location

Sanitas Diagnosztikai és Rehabilitációs Központ

Gyula, 5700, Hungary

Location

Futurenest Kft.

Miskolc, 3527, Hungary

Location

Azienda ospedalo universitaria

Parma, Parma, 43100, Italy

Location

Universita degli Studi di Pavia - Fondazione IRCCS Policlini

Pavia, Pavia, 27100, Italy

Location

SO S.Chiara, AOU Pisana

Pisa, Pisa, 56126, Italy

Location

Osp.Pediatr.Giov.XXIII,AOUC P.Bari

Bari, 70126, Italy

Location

ASST Papa GiovanniXXIII,Mat.Inf.Ped

Bergamo, 24127, Italy

Location

Malopolskie Centrum Alergologii

Krakow, Lesser Poland Voivodeship, 31-624, Poland

Location

ALERGO-MED Specjalistyczna Przychodnia Lekarska Spolka z o.o.

Tarnów, Lesser Poland Voivodeship, 33-100, Poland

Location

Centrum Alergologii Specjalistyczna Przychodnia Alergologiczna

Lublin, Lublin Voivodeship, 20-552, Poland

Location

WWCOiT im. M. Kopernika w Lodzi, Osrodek Pediatryczny im. dr J.Korczaka

Lodz, Lódzkie, 90-329, Poland

Location

NZOZ E-Vita

Bialystok, Podlaskie Voivodeship, 15-879, Poland

Location

Centrum Medyczne Pratia Czestochowa

Częstochowa, Silesian Voivodeship, 42-217, Poland

Location

NZLA Michalkowice - Jarosz i Partnerzy Spolka Lekarska

Siemianowice Śląskie, Silesian Voivodeship, 41-103, Poland

Location

Centrum Medyczne PROMED

Krakow, 31-411, Poland

Location

Podkarpacki Osrodek Pulmonologii i Alergologii Sp. z o.o.

Rzeszów, 35-612, Poland

Location

Velocity Skierniewice Sp. z o.o.

Skierniewice, 96-100, Poland

Location

Przychodnia Specjalistyczna Prosen-Med NZOZ

Warsaw, 01-231, Poland

Location

NSZOZ Puls - Med Anna Bogusz, Agnieszka Musielak Sp.J.

Skarżysko-Kamienna, Świętokrzyskie Voivodeship, 26-110, Poland

Location

Inselspital Bern Kinderklinik

Bern, Canton of Bern, 3010, Switzerland

Location

CHUV-Centre Hopitalier Universitaire Vaudois

Lausanne, Canton of Vaud, 1011, Switzerland

Location

Hôpitaux Universitaires de Genève (HUG)

Geneva, 1205, Switzerland

Location

Universitaets-Kinderklinik - Kinderspital Zuerich

Zurich, 8032, Switzerland

Location

Brighton And Sussex University Hospitals NHS Trust

Brighton, East Sussex, BN2 5BE, United Kingdom

Location

Royal Manchester Children's Hospital - Paediatrics - Paediatrics

Manchester, Manchester, M13 9WL, United Kingdom

Location

Nottingham University Hospitals NHS Trust - Queen's Medical Centre

Nottingham, Nottingham, NG7 2UH, United Kingdom

Location

Royal Hospital for Children and Young People

Edinburgh, EH9 1LF, United Kingdom

Location

Royal London Hospital

London, E1 4NS, United Kingdom

Location

King's College Hospital

London, SE5 9RS, United Kingdom

Location

MeSH Terms

Conditions

Respiratory Tract Infections

Condition Hierarchy (Ancestors)

Infections; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2022
• First Posted: January 10, 2023
• Study Start: December 12, 2022
• Primary Completion: March 10, 2026
• Study Completion (Estimated): September 16, 2026
• Last Updated: March 24, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (5); GB (6); PL (12); DE (9); CH (4); HU (6)