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Epidemiology of the Nasal Flora at the Reference Center for Cystic Fibrosis of Queen Fabiola Children's University Hospital.

NCT03911258 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2019-04-16

No results posted yet for this study

Summary

Cystic fibrosis (CF) is the most common autosomal recessive inherited genetic disorder in North America, Australia and Europe.

CF is due to cystic fibrosis transmembrane conductance regulator gene mutation (CFTR) coding for a chloride channel located at the apical membrane of epithelial cells. The most common mutation is the deletion of the amino acid phenylalanine at the codon 508 (ΔF508) affecting 70% of the patients.

The CFTR channel participates in the regulation of the volume and composition of exocrine secretions. At the level of the lungs, this results in a thickening of the mucus with a dysfunction of the mucociliary clearance promoting colonization of pathogenic microorganisms. Patients with cystic fibrosis therefore have a natural susceptibility to develop acute and then chronic respiratory infections, gradually leading to irreversible respiratory tract lesions called bronchiectasis. Different germs such as Haemophilus influenzae and Staphylococcus aureus colonize the airways early in life. The progression of the disease causes furthermore a colonization by opportunistic germs such as Pseudomonas aeruginosa and Burkholderia cepacia, which are associated with higher mortality.

Pulmonary exacerbation is a common complication of CF requiring administration of antibiotics. The choice of these antibiotics depends on the germs that the patient carries in his respiratory tract.

The type of sampling and the conditions under which they are taken are therefore very important. Sputum and oropharyngeal smear are used in adolescents and children respectively to collect respiratory secretions in clinical routine. The recent literature describes induced sputum, obtained after a physiotherapy session and a hypertonic serum aerosol, as superior to the oropharyngeal smear alone and equivalent to bronchoalveolar lavage for the evaluation of the microbiological profile of patients who cannot expectorate. However, this technique takes time and requires the presence of a physiotherapist.

Bronchoalveolar lavage is reserved for complex cases that do not respond to standard treatments.

Finally, the nasal flora appears to be involved in the colonization of the lower respiratory tract. Sinuses are described as reservoirs of germs that can induce a recolonization of the lungs despite eradication of the germ (for example after a pulmonary transplantation) .

To our knowledge, no study has investigated the involvement of nasal flora in the clinical course of children with CF.

Conditions

Interventions

PROCEDURE

nasopharyngeal swab versus nasal wash

The type of procedure will be determine according to patient collaboration

Sponsors & Collaborators

  • Queen Fabiola Children's University Hospital

    lead OTHER

Principal Investigators

  • Jean-Christophe Beghin, MD · Queen Fabiola Children's University Hospital

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-02-06
Primary Completion
2020-04-30
Completion
2020-04-30

Countries

  • Belgium

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03911258 on ClinicalTrials.gov