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

• Status: Recruiting
• Trial end date: 2025-06-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: OM Pharma

Criteria

Inclusion Criteria:

• Children of either gender aged between 6 months and 5 years, 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 respiratory chronic diseases (e.g., tuberculosis, cystic fibrosis).

• Any autoimmune disease.

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

• 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. Systemic or oral steroids (e.g., oral prednisolone) 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.