Clinical trial NCT03947957: Microbial Biomarkers of EArly Pseudomonas Aeruginosa Colonization in CHildren With Cystic Fibrosis
Official title: Microbial Biomarkers of EArly Pseudomonas Aeruginosa Colonization in CHildren With Cystic Fibrosis
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Cystic Fibrosis
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2019-05-13
Enrollment: 70
Sex: ALL
Minimum age (years): 2
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Infants will be included between the 2nd visit to the CRCM (about 2 months of age) and the 6th month then they will be followed until the age of 36 months. The pace of visits will be based on the usual follow-up rate of CF infants.
Primary purpose: DIAGNOSTIC

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Presence of P. aeruginosa in bacterial sputum cultures collected at 36 months of age
timeFrame: 36 months
Secondary outcomes:
measure: Absolute amount of P. aeruginosa at different sampling times.
timeFrame: 36 months
measure: Absolute amount of P. catoniae in respiratory secretions at different sampling times and Delta between 12, 24 and 36 months.
timeFrame: 36 months
measure: Absolute amount of P. catoniae in stool at different sampling times and Delta between 12, 24 and 36 months.
timeFrame: 36 months
measure: Level of dysbiosis
timeFrame: 36 months
Other outcomes:
Locations:
city: Angers
country: France
facility: CHRU Angers
city: Bordeaux
country: France
facility: Hôpital des Enfants Bordeaux
city: Grenoble
country: France
facility: CHU Grenoble
city: Lyon
country: France
facility: Hôpital Femme-Mère-Enfant Lyon
city: Nantes
country: France
facility: CHRU Nantes
city: Paris
country: France
facility: Hôpital Necker
city: Paris
country: France
facility: Hôpital Trousseau
city: Rennes
country: France
facility: CHRU Rennes
city: Roscoff
country: France
facility: Centre de Perharidy
city: Rouen
country: France
facility: Hôpital Charles Nicolle Rouen
city: Tours
country: France
facility: CHRU de Tours
Study officials:
affiliation: University Hospital, Brest
name: Genevieve HERY-ARNAUD, Pr
role: PRINCIPAL_INVESTIGATOR
References: