Airway Microbiome of Patients With Protracted Bacterial Bronchitis

Antwerp University Hospital (UZA)

Status: Not yet enrolling

Conditions: Protracted Bacterial Bronchitis

Study type: Observational

Funder types: Other

Identifiers

NCT07255430

BUN B3002025000069

Details and patient eligibility

About

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.

Full description

Protracted Bacterial Bronchitis (PBB) is an often underestimated disease, characterized by a persistent cough for more than four weeks, without other significant underlying symptoms. While generally treatable, it can lead to complications such as recurrent infections and airway damage (bronchiectasis). The reasons why some children develop PBB or subsequent complications while others do not remain unclear. Recent research suggests that an impaired immune response and microbiota dysbiosis may play a key role. This study aims to analyze the microbial and viral composition of the airways in children with PBB, its relationship with inflammation, and the effects of azithromycin. Oropharyngeal swabs will be collected from up to 160 children <5 years old diagnosed with PBB at UZA in a longitudinal setup during one year. At each routine consultation (five in total) and during an exacerbation episode, three oropharyngeal swabs will be collected from each child. The three swabs will be used to: (1) determine the microbiome composition using next-generation sequencing, (2) identify the virome composition using multiplex qPCR or similar approaches, and (3) quantify immune biomarkers (RNA and protein-level) and culture microbial isolates. These findings will help to better understand the role of the airway microbiome in young children with PBB and identify microorganisms that may have a pathogenic or protective role. Ultimately, this knowledge may contribute to the development of new and effective diagnostics and treatments for PBB from an early age.

Enrollment: 160 estimated patients

Sex: All

Ages: Under 5 years old

Volunteers: No Healthy Volunteers

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.

Trial design

160 participants in 1 patient group

Participants with Protracted bacterial bronchitis diagnostic

Description:

Children under five years old who attend pediatric outpatient visits or well-child visits at University Hospital Antwerp (UZA) and are diagnosed with Protracted bacterial bronchitis.