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NCT Number: NCT07255430

Airway Microbiome of Patients With Protracted Bacterial Bronchitis

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.

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Key information

Age range

Up to 5 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Antwerp University Hospital

Edegem, 2650, Belgium

Location status: Recruiting

Location contact

Kim Van Hoorenbeeck, Prof. dr.

CONTACT

[email protected]

+3238213000

Kim Van Hoorenbeeck, Prof. dr.

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Analysis of respiratory microbiome composition

    Time frame: 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.

  2. Prevalence of respiratory viruses

    Time frame: 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 outcomes

  1. Immune biomarkers profiling in airway samples

    Time frame: 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).

  2. Correlates of respiratory microbiome

    Time frame: 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).

  3. Correlates of Protracted Bacterial Bronchitis

    Time frame: 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Irina Spacova, Prof. dr. ir.

CONTACT

[email protected]

+3232653289

Kim Van Hoorenbeeck, Prof. dr.

CONTACT

[email protected]

+3238213000

Sponsors and collaborators

Lead sponsor

University Hospital, Antwerp

Other

Registry information

Official study title

Interaction Between Microbiome, Virome and Host Immunity Response in the Context of Protracted Bacterial Bronchitis

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
Dec 1, 2025
Registry last updated
Mar 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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