NCT07255430

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P50-P75 for all trials

Timeline
32mo left

Started Jan 2026

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress11%
Jan 2026Jan 2029

First Submitted

Initial submission to the registry

October 1, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

December 1, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

January 7, 2026

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2028

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2029

Last Updated

March 19, 2026

Status Verified

September 1, 2025

Enrollment Period

2 years

First QC Date

October 1, 2025

Last Update Submit

March 18, 2026

Conditions

Protracted Bacterial Bronchitis

Keywords

coughProtracted Bacterial Bronchitismicrobiome

Outcome Measures

Primary Outcomes (2)

  • Analysis of respiratory microbiome composition

    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.

    Baseline, 3 months, 6 months, 9 months, 12 months and during exacerbations

  • Prevalence of respiratory viruses

    Description: Detection of respiratory viruses from airway samples using RT-qPCR. Unit of Measure: percentage of positive samples (in percentages).

    Baseline, 3 months, 6 months, 9 months, 12 months and during exacerbations

Secondary Outcomes (3)

  • Immune biomarkers profiling in airway samples

    Baseline, 3 months, 6 months, 9 months, 12 months and during exacerbations

  • Correlates of respiratory microbiome

    Baseline, 3 months, 6 months, 9 months, 12 months and during exacerbations

  • Correlates of Protracted Bacterial Bronchitis

    Baseline, 3 months, 6 months, 9 months, 12 months and during exacerbations

Study Arms (1)

Participants with Protracted bacterial bronchitis diagnostic

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.

Eligibility Criteria

AgeUp to 5 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

Children under five years old diagnosed with PBB.

You may qualify if:

  • Children with PBB diagnosis according to case definition
  • Consent form signed by parents or legal guardians

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Antwerp University Hospital

Edegem, 2650, Belgium

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Oropharyngeal swabs

MeSH Terms

Conditions

Cough

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Kim Van Hoorenbeeck, Prof. dr.

    University Hospital, Antwerp

    PRINCIPAL INVESTIGATOR

  • Irina Spacova, Prof. dr. ir.

    Universiteit Antwerpen

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kim Van Hoorenbeeck, Prof. dr.

CONTACT

+3238213000kim.vanhoorenbeeck@uza.be

Irina Spacova, Prof. dr. ir.

CONTACT

+3232653289irina.spacova@uantwerpen.be

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
12 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 1, 2025

First Posted

December 1, 2025

Study Start

January 7, 2026

Primary Completion (Estimated)

January 1, 2028

Study Completion (Estimated)

January 1, 2029

Last Updated

March 19, 2026

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will share

The metadata of participants in the study will be made available in a restricted access repository. For samples and data sharing, the researchers will work with the legal department to establish Material/Data Transfer Agreements. Sequencing data are available at the European Nucleotide Archive. Physical samples are their origin will be stored at the decentral hub of the Antwerp biobank.

Time Frame
After the completion of the study (intended in 2029) and before publication, sequences and related metadata will be deposited into the ENA database and made available indefinitely.
Access Criteria
After data deposition in ENA, the data will be publicly accessible to anyone using the ENA instructions https://www.ebi.ac.uk/ena/browser/downloading-data

Locations

BE(1)