Protracted Bacterial Bronchitis
Conditions
Keywords
cough, Protracted Bacterial Bronchitis, microbiome
Brief 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.
Detailed 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.
Interventions
None listed
Sponsors
University Hospital, Antwerp
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
No minimum to 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Immune biomarkers profiling in airway samples | Baseline, 3 months, 6 months, 9 months, 12 months and during exacerbations | Immunological profiling will be performed in airway samples by determining (1) cytokine concentrations based on protein-level analysis such as ELISA (pg/mL) and/or (2) differential gene expression based on RNA analysis (log fold-change or similar metric). |
| Correlates of respiratory microbiome | Baseline, 3 months, 6 months, 9 months, 12 months and during exacerbations | Description: Microbial profiles will be associated with demographic, epidemiological and clinical data collected through standardized questionnaires and clinical assessments to determine relevant correlates. Unit of Measure: Statistical association measure (e.g., correlation coefficients or similar). |
| Correlates of Protracted Bacterial Bronchitis | Baseline, 3 months, 6 months, 9 months, 12 months and during exacerbations | PBB events will be associated with demographic, epidemiological and clinical data collected through standardized questionnaires and clinical assessments to determine relevant correlates. Unit of Measure: Effect estimates (odds/prevalence/hazard ratios or similar). |
Countries
Belgium
Contacts
CONTACTKim Van Hoorenbeeck, Prof. dr.
CONTACTIrina Spacova, Prof. dr. ir.
PRINCIPAL_INVESTIGATORKim Van Hoorenbeeck, Prof. dr.
University Hospital, Antwerp
PRINCIPAL_INVESTIGATORIrina Spacova, Prof. dr. ir.
Universiteit Antwerpen
Outcome results
None listed