Airway microbiome in young children with protracted bacterial bronchitis
Official title: Interaction Between Microbiome, Virome and Host Immunity Response in the Context of Protracted Bacterial Bronchitis
Run by University Hospital, Antwerp · NCT07255430 · Data updated 2026-11-12
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 |
|---|---|
| Ages | Any age to 5 Years |
| Sex | All |
| Enrollment | 160 (estimated) |
| Sponsor | University Hospital, Antwerp Academic / other |
| Locations | 1 site (Edegem) |
| Status | Recruiting |
| Started | January 7, 2026 |
| Main results expected | January 2028 |
| Study ends | January 2029 |
| Registry record updated | March 19, 2026 |
| Trial ID | NCT07255430 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Lung MRI for children with protracted bacterial bronchitis (PBB)
We will try using MRI to look at the lungs of children aged 5–17 with suspected PBB so they might avoid anaesthesia and radiation from bronchoscopy and CT.
-
Biomarkers and Respiratory Omics in Children: Predicting Disease Course
This study tests whether biomarkers from the lungs and blood can predict how asthma and protracted bacterial bronchitis in children will progress and respond to current therapies.
-
Using antibiotics to treat chronic wet cough in children
This study is testing whether giving antibiotics can help young children with a long-lasting wet cough feel better and reduce the chances of their symptoms coming back.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.