Status:
RECRUITING
Patienthèque of Finisterian (South of Brittany) Children With Cystic Fibrosis in the Time of Precision Medicine
Lead Sponsor:
University Hospital, Brest
Conditions:
Cystic Fibrosis
Eligibility:
All Genders
Up to 18 years
Phase:
NA
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 t...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 21 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2030
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04137133
Start Date
March 21 2022
End Date
March 1 2030
Last Update
April 23 2024
Active Locations (1)
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1
Fondation Ildys
Roscoff, France, 29684