Patienthèque of Finisterian (South of Brittany) Children With Cystic Fibrosis in the Time of Precision Medicine.Descriptive Monocentric Study for Identification and Validation of Biomarkers Predictive of Clinical Evolution
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Cystic Fibrosis
- Sponsor
- University Hospital, Brest
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Presence of P. aeruginosa in bacterial sputum cultures in one of bronchial secretions sample
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Presence of P. aeruginosa in bacterial sputum cultures in one of bronchial secretions sample
Time Frame: 3 years
Analyse with Porphyromonas predictive biomarker of the risk of P. aeruginosa primocolonization.