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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-02

Study Completion Date

2026-07-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Cystic Fibrosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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 Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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collection of expectoration, stools and blood

Group Type OTHER

collection of expectoration, stools and blood

Intervention Type DIAGNOSTIC_TEST

collection of expectoration, stools and blood

Interventions

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collection of expectoration, stools and blood

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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

Minimum Eligible Age

2 Months

Maximum Eligible Age

6 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No