Patienthèque of Finisterian (South of Brittany) Children With Cystic Fibrosis in the Time of Precision Medicine

University Hospital, Brest20 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Cystic Fibrosis

Interventions

collectionDIAGNOSTIC_TEST

bronchial secretions, blood, stools, superficial skin sample, dental plaque sample and urine

Eligibility

Sex: ALLMax age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Fondation Ildys

Roscoff, France

RECRUITING

Outcomes

Primary Outcomes

Presence of P. aeruginosa in bacterial sputum cultures in one of bronchial secretions sample

Analyse with Porphyromonas predictive biomarker of the risk of P. aeruginosa primocolonization.

Time frame: 3 years

Central Contacts

Geneviève HERY-ARNAUD

CONTACT

0298145102 Genevieve.Hery-Arnaud@univ-brest.fr

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.