Microbial Biomarkers of EArly Pseudomonas Aeruginosa Colonization in CHildren With Cystic Fibrosis (BEACH)

Regional University Hospital Center (CHRU)

Status

Active, not recruiting

Conditions

Cystic Fibrosis

Treatments

Diagnostic Test: collection of expectoration, stools and blood

Study type

Interventional

Funder types

Other

Identifiers

NCT03947957

BEACH (29BRC19.0065)

Details and patient eligibility

About

The objective of this study is to evaluate the predictive nature of the biomarker Porphyromonas catoniae measured at the age of 12 months in the occurrence of colonization with Pseudomonas aeruginosa at 36 months of age in children with cystic fibrosis.

Full description

This is a multicentric 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

The clinical data as well as samples (expectorations, stools) will be collected on a monthly basis up to 6 months old and then every 2 months until one year old and finally quarterly until 3 years old.

Tracheo-bronchial secretions will be collected at the CRCM
Stools samples will be carried out by the parents prior to consultation with the CRCM
A blood collection will be carried out annually in an annual report.

Enrollment

70 patients

Sex

All

Ages

2 to 6 months old

Volunteers

No Healthy Volunteers

Inclusion criteria

Infants aged 6 months maximum at inclusion with a confirmed diagnosis of cystic fibrosis in its classical form (positive sweat test and/or two mutations of the CFTR gene from class I to III)
Children free from any antecedent of colonization to P. aeruginosa at the time of inclusion (certified by the microbiological history supplemented by a molecular test by qPCR according to the diagram of Le gal et al., 2013)-Affiliation to the social security system
Consent signed by the holders of parental authority or the sole parent holding parental authority / and "oral" agreement of the second holder

Exclusion criteria

Severe acute pathology (other than cystic fibrosis) in progress, or requiring surgery
Children unable to undergo the tests required for the Protocol
Children whose parent (s) is (are) minor (s)
Children whose parental authority does not master the French language
Refusal to participate in the study