NCT03911258: FLONAMUC

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

Status unknown NA Last updated 16 April 2019

What this trial tests

NA trial testing nasopharyngeal swab versus nasal wash in Cystic Fibrosis in 70 participants. Status unknown.

Timeline

6 February 2019

Primary endpoint
30 April 2020

30 April 2020

Quick facts

Lead sponsor	Queen Fabiola Children's University Hospital
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	diagnostic
Enrollment	70
Start date	6 February 2019
Primary completion	30 April 2020
Estimated completion	30 April 2020
Sites	1 location across Belgium

Drugs / interventions tested

• nasopharyngeal swab versus nasal wash

Conditions studied

• Cystic Fibrosis — all drugs for Cystic Fibrosis →

Sponsor

Queen Fabiola Children's University Hospital

Who can join

Under 20, any sex, with Cystic Fibrosis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.