Cystic Fibrosis Clinical Trial
— FLONAMUCOfficial title:
Epidemiology of the Nasal Flora at the Reference Center for Cystic Fibrosis of Queen Fabiola Children's University Hospital.
Verified date | March 2019 |
Source | Queen Fabiola Children's University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Enrolling by invitation |
Enrollment | 70 |
Est. completion date | April 30, 2020 |
Est. primary completion date | April 30, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 20 Years |
Eligibility |
Inclusion Criteria: - Cystic fibrosis patients aged 0-20y followed in Cystic fibrosis at HUDERF - For each participant, both parents or legally acceptable representative(s) must sign an informed consent form (ICF) indicating that they understand the purpose of, and procedures required for, the study and is willing to allow the child to participate in the study. - Assent is also required of children capable of understanding the study (typically participants 7 years of age and older). Exclusion Criteria: Any clinical situation that prohibit the taking of samples as defined in this protocol: - Severe respiratory distress - An altered state of consciousness - A pulmonary complication contrary to the realization of respiratory physiotherapy (pneumothorax, hemoptysis). |
Country | Name | City | State |
---|---|---|---|
Belgium | Hôpital Universitaire Des Enfants Reine Fabiola | Brussels |
Lead Sponsor | Collaborator |
---|---|
Queen Fabiola Children's University Hospital |
Belgium,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | concordance between the microbiological results obtained by nasal lavage or swab and sputum in children | To see if there is any correlation in the cultures of pathogens present in the upper and lower respiratory tracts for any combination of samples taken | Day 1 | |
Secondary | Impact of upper respiratory microbial flora in the patient clinical course | To see if there is any correlation between the presence of pathogens in upper respiratory tract (URT) and the alteration of one or more clinical parameters at the time of sampling (BMI, FEV1, FVC, FEF25/75, Number of exacerbations) | Day 60 | |
Secondary | Safety evaluation of the of the different methods of sampling | Type, frequency, severity and relationship between adverse events observed and sampling procedures performed. | Day 1 | |
Secondary | Tolerance of the different methods of sampling | Pain / discomfort score induced by the set of sampling procedures measured by means of the "Visual Analogue Scale" (VAS) in children aged 5 or older. The Visual Analogue Scale (VAS) consists of a straight line with the endpoints defining extreme limits such as 'no pain at all' (0) and 'pain as bad as it could be' (10). The patient is asked to mark his pain level on the line between the two endpoints. The distance between 'no pain at all' and the mark then defines the subject's pain. | Day 1 | |
Secondary | Tolerance of the different methods of sampling | Pain / discomfort score induced by the set of sampling procedures measured by means of the FLACC scale (Face, Legs, Activity, Cry, Consolability Scale) in children less than 5 years. FLACC scale is a measurement used to assess pain for children between the ages of 2 months and 7 years or individuals that are unable to communicate their pain. The scale is scored in a range of 0-10 with 0 representing no pain. The scale has five criteria, which are each assigned a score of 0, 1 or 2. The criteria evaluated are expression of the face, position of the legs, patient activity, type of cry, consolability | Day 1 | |
Secondary | Tolerance of the different methods of sampling | Percentage of Drop-out for refusal of nasal sampling | Day 60 |
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