Airway microbiome in young children with protracted bacterial bronchitis
Interaction Between Microbiome, Virome and Host Immunity Response in the Context of Protracted Bacterial Bronchitis
This project will see if the types of bacteria, viruses, and immune markers in the airways change over time in children under 5 with protracted bacterial bronchitis and whether standard azithromycin treatment alters them.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 160 (estimated) |
| Ages | N/A to 5 Years |
| Sex | All |
| Sponsor | University Hospital, Antwerp Academic / other |
| Locations | 1 site (Edegem) |
| Trial ID | NCT07255430 on ClinicalTrials.gov |
What this trial studies
Children under five with protracted bacterial bronchitis will be followed for one year with oropharyngeal swabs collected at five routine visits and during any exacerbations. Each visit provides three swabs used for bacterial microbiome sequencing, viral detection, and immune biomarker (RNA and protein) measurement, with culture of isolates where possible. The study compares microbial, viral, and immune patterns over time and in relation to standard azithromycin treatment. Results aim to identify organisms or immune signatures linked to worsening, protection, or treatment effects in PBB.
Who should consider this trial
Good fit: Ideal candidates are children under five with a current diagnosis of protracted bacterial bronchitis whose parents or guardians can provide consent and who have not had recent hospitalization or antibiotic therapy.
Not a fit: Children with other chronic respiratory diseases (such as cystic fibrosis or non-PBB bronchiectasis), recent serious infections, recent antibiotic use, or a history of mechanical ventilation are excluded and unlikely to benefit from the study.
Why it matters
Potential benefit: If successful, the findings could identify airway microbes or immune signals that predict complications or guide more targeted antibiotic or preventive strategies for young children with PBB.
How similar studies have performed: Previous microbiome and virome studies in pediatric respiratory conditions have provided useful insights, but longitudinal, PBB-specific data are limited, making this approach partly novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Edegem
- Antwerp University Hospital — Edegem, Belgium (Recruiting)
Study contacts
- Principal investigator: Kim Van Hoorenbeeck, Prof. dr. — University Hospital, Antwerp
- Study coordinator: Kim Van Hoorenbeeck, Prof. dr.
- Email: kim.vanhoorenbeeck@uza.be
- Phone: +3238213000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.