- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03911258
Epidemiology of the Nasal Flora at the Reference Center for Cystic Fibrosis of Queen Fabiola Children's University Hospital. (FLONAMUC)
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Brussels, Belgium, 1020
- Hôpital Universitaire des Enfants Reine Fabiola
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: DIAGNOSTIC
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Nasal flora in CF patient
|
The type of procedure will be determine according to patient collaboration
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
concordance between the microbiological results obtained by nasal lavage or swab and sputum in children
Time Frame: Day 1
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Impact of upper respiratory microbial flora in the patient clinical course
Time Frame: Day 60
|
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
|
Safety evaluation of the of the different methods of sampling
Time Frame: Day 1
|
Type, frequency, severity and relationship between adverse events observed and sampling procedures performed.
|
Day 1
|
Tolerance of the different methods of sampling
Time Frame: Day 1
|
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
|
Tolerance of the different methods of sampling
Time Frame: Day 1
|
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
|
Tolerance of the different methods of sampling
Time Frame: Day 60
|
Percentage of Drop-out for refusal of nasal sampling
|
Day 60
|
Collaborators and Investigators
Investigators
- Principal Investigator: Jean-Christophe Beghin, MD, Queen Fabiola Children's University Hospital
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- P2018/PNEUMO/FLONAMUC
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Cystic Fibrosis
-
Hospital de Clinicas de Porto AlegreUnknownCystic Fibrosis | Cystic Fibrosis Pulmonary Exacerbation | Cystic Fibrosis in Children | Cystic Fibrosis With ExacerbationBrazil
-
University of Colorado, DenverCystic Fibrosis FoundationTerminatedCystic Fibrosis-related Diabetes | Cystic Fibrosis Pulmonary Exacerbation | Cystic Fibrosis in ChildrenUnited States
-
Royal College of Surgeons, IrelandThe Hospital for Sick Children; Imperial College London; Erasmus Medical Center; University College Dublin and other collaboratorsActive, not recruitingCystic Fibrosis | Adherence, Medication | Cystic Fibrosis Gastrointestinal Disease | Cystic Fibrosis in Children | Cystic Fibrosis Liver DiseaseUnited Kingdom, Ireland
-
Herlev and Gentofte HospitalCopenhagen University Hospital, DenmarkActive, not recruitingMyocardial Infarction | Heart Diseases | Heart Failure | Stroke | Cystic Fibrosis | Heart Failure, Diastolic | Heart Failure, Systolic | Left Ventricular Dysfunction | Cystic Fibrosis-related Diabetes | Cystic Fibrosis Gastrointestinal Disease | Cystic Fibrosis of Pancreas | Cystic Fibrosis, Pulmonary | Cystic...Denmark
-
The Hospital for Sick ChildrenCanadian Cystic Fibrosis FoundationActive, not recruitingCystic Fibrosis | Cystic Fibrosis Gastrointestinal Disease | Cystic Fibrosis in ChildrenCanada
-
Arrowhead PharmaceuticalsTerminatedCystic Fibrosis, PulmonaryAustralia, New Zealand
-
AzurRx SASCompletedCystic Fibrosis | Cystic Fibrosis Gastrointestinal Disease | Cystic Fibrosis of PancreasTurkey, Hungary
-
Dartmouth-Hitchcock Medical CenterTrustees of Dartmouth CollegeWithdrawnCystic Fibrosis-related Diabetes | Cystic Fibrosis Liver Disease | CF - Cystic FibrosisUnited States
-
University Hospital, BordeauxCompleted
-
University of PortsmouthUniversity Hospital Southampton NHS Foundation Trust; Loughborough University; Queen Alexandra HospitalTerminated
Clinical Trials on nasopharyngeal swab versus nasal wash
-
LumiraDx UK LimitedActive, not recruitingCOVID-19United States
-
LumiraDx UK LimitedActive, not recruiting
-
Rochester General HospitalActive, not recruitingDynamic Change and Immune Response to Nasopharyngeal Carriage and Acute Otitis Media Pathogens (AOM)Acute Otitis MediaUnited States
-
Center for Primary Care and Public Health (Unisante)...Centre Hospitalier Universitaire VaudoisUnknownCOVID-19 | SARS-CoV-2Switzerland
-
Assistance Publique Hopitaux De MarseilleCompleted
-
Public Health EnglandCompletedNasal Carriage of PneumococciUnited Kingdom
-
Assistance Publique Hopitaux De MarseilleCompleted
-
Assistance Publique Hopitaux De MarseilleCompleted
-
St. Jude Children's Research HospitalNational Institute of Allergy and Infectious Diseases (NIAID); The University...Completed
-
Wyeth is now a wholly owned subsidiary of PfizerCompletedStreptococcus Pneumoniae InfectionsChina