Ireland
--:--IST
Recruiting Observational

Airway Microbiome of Patients With Protracted Bacterial Bronchitis

NCT07255430 · tracked via the Priya Life Science Belgium tracker
Phase
Observational
Started
2026-01-07
Last updated
2026-03-19

Condition(s) studied

Protracted Bacterial Bronchitis

Study summary

This project aims to assess the relationship between the microbiome and virome composition, the immune responses, and the respiratory health of children with protracted bacterial bronchitis (PBB). In addition, we aim to evaluate how the standard treatment with azithromycin interacts with the components of the microbiome, virome and immune biomarkers.

Eligibility

Sex
ALL
Min age
—
Max age
5 Years
Healthy volunteers
No
Inclusion Criteria: * Children with PBB diagnosis according to case definition * Consent form signed by parents or legal guardians Exclusion Criteria: * Comorbidities (HIV, asthma, chronic obstructive pulmonary disease, diabetes) * Have had serious illnesses (meningitis, pneumonia, bacteremia, empyema, etc) in the previous three months, identified only at the time of enrollment. * Have chronic respiratory conditions at the time of enrollment (non-PBB bronchiectasis not caused by PBB, CF, allergy, etc.). * Having received mechanical ventilation. * Having been hospitalized or used antibiotics in the previous three months at the time of enrollment.

Primary outcome measure(s)

  • Analysis of respiratory microbiome composition — Baseline, 3 months, 6 months, 9 months, 12 months and during exacerbations
    Description: Analysis of microbiome communities in airway samples will be performed using amplicon or shotgun sequencing to determine relative microbial abundances (in percentages) as the unit of measure, coupled with the use of bioinformatic tools for community structure analysis.
  • Prevalence of respiratory viruses — Baseline, 3 months, 6 months, 9 months, 12 months and during exacerbations
    Description: Detection of respiratory viruses from airway samples using RT-qPCR. Unit of Measure: percentage of positive samples (in percentages).

Trial sites (1)

FacilityCityRegionStatus
Antwerp University Hospital Edegem Belgium Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07255430 on ClinicalTrials.gov ↗ ← All trials in Belgium