Cystic Fibrosis
Conditions
Brief summary
The objective of this study is to evaluate the relevance of Porphyromonas as a biomarker predicting the risk of P. aeruginosa primocolonization in children form 0 to 18 years old with cystic fibrosis.
Detailed description
This is a monocentric study in 3 phases: * Pre-inclusion: at the first visit to the CRCM (support for a positive screening confirmed by sweat test and genotyping CFTR) * Inclusion: possible between the 2nd visit to the CRCM (about 2 months old) and the 6th month * Follow-up: up to 36 months old. The pace of visits will be based on the usual follow-up rate of CF infants Clinical and paraclinical data and samples will be collected as part of the usual follow-up of CF children. Inclusions and follow-up visits will be carried out at the Roscoff CRCM as well as respiratory explorations and biological samples. Dermatological and odontological follow-ups will be scheduled for each patient at the rate of an annual visit to the CHRU in Brest in the relevant departments.
Interventions
DIAGNOSTIC_TESTcollection
bronchial secretions, blood, stools, superficial skin sample, dental plaque sample and urine
Sponsors
University Hospital, Brest
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 18 Years
Healthy volunteers
No
Inclusion criteria
* Newly screened infants with a confirmed diagnosis of cystic fibrosis in its classic form (clinical symptoms and two positive sweat tests and/or two mutations of the cftr gene from Class I to III) * Children free of any colonization with P. aeruginosa * Affiliation with the social security system * Consent signed by the holders of parental authority or the sole parent holding parental authority
Exclusion criteria
* Children colonized with P. aeruginosa according to the cytobacteriological examination and / or molecular test of sputum or pharyngeal specimens * Children grafted * Children not affiliated to a social security scheme or not entitled to * Children whose parent (s) are (are) minor (s) * Children whose holders of parental authority do not master the French language * Refusal to participate in the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Presence of P. aeruginosa in bacterial sputum cultures in one of bronchial secretions sample | 3 years | Analyse with Porphyromonas predictive biomarker of the risk of P. aeruginosa primocolonization. |
Countries
France
Contacts
Primary ContactGeneviève HERY-ARNAUD
Outcome results
None listed