Airway Microbiome of Patients With Protracted Bacterial Bronchitis
ConditionProtracted Bacterial Bronchitis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeUp to 5
SponsorUniversity Hospital, Antwerp
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Children with PBB diagnosis according to case definition
Consent form signed by parents or legal guardians
Disqualifiers
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.
Trial population
Children under five years old diagnosed with PBB.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
160 Participants
are grouped into 1 trial groupGroup A: Participants with Protracted bacterial bronchitis diagnostic
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline, 3 months, 6 months, 9 months, 12 months and during exacerbations2
Prevalence of respiratory viruses
Description: Detection of respiratory viruses from airway samples using RT-qPCR. Unit of Measure: percentage of positive samples (in percentages).
Time frame
Baseline, 3 months, 6 months, 9 months, 12 months and during exacerbationsSecondary outcomes
1
Immune biomarkers profiling in airway samples
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).
Time frame
Baseline, 3 months, 6 months, 9 months, 12 months and during exacerbations2
Correlates of respiratory microbiome
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).
Time frame
Baseline, 3 months, 6 months, 9 months, 12 months and during exacerbations3
Correlates of Protracted Bacterial Bronchitis
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).
Time frame
Baseline, 3 months, 6 months, 9 months, 12 months and during exacerbationsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov