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

Study Overview
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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.

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.

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

Conditions
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Cystic Fibrosis

Intervention / Treatment
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* Diagnostic Test: collection of expectoration, stools and blood


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 2 Months
Maximum Age: 6 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Interventional 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: collection of expectoration, stools and blood<br> | Diagnostic Test: collection of expectoration, stools and blood<br>* collection of expectoration, stools and blood<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence of P. aeruginosa in bacterial sputum cultures collected at 36 months of age |  | 36 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absolute amount of P. aeruginosa at different sampling times. |  | 36 months | 
| Absolute amount of P. catoniae in respiratory secretions at different sampling times and Delta between 12, 24 and 36 months. |  | 36 months | 
| Absolute amount of P. catoniae in stool at different sampling times and Delta between 12, 24 and 36 months. |  | 36 months | 
| Level of dysbiosis |  | 36 months |