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Clinical Trials in France / NCT03947957
Active, not recruiting Not applicable

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

NCT03947957 · tracked via the Priya Life Science France tracker
Phase
Not applicable
Started
2020-10-02
Last updated
2026-06-16

Condition(s) studied

Cystic Fibrosis

Investigational drug(s) / intervention(s)

collection of expectoration, stools and blood

collection of expectoration, stools and blood: collection of expectoration, stools and blood

Study 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.

Eligibility

Sex
ALL
Min age
2 Months
Max age
6 Months
Healthy volunteers
No
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 illness (other than cystic fibrosis) ongoing, or requiring surgery * Children unable to undergo the tests required by the protocol * Children whose parent(s) is/are minors * Children whose legal guardians do not have sufficient command of the French language * Children under exclusive parenteral nutrition * Refusal to participate in the study

Primary outcome measure(s)

Trial sites (11)

FacilityCityRegionStatus
CHRU Angers Angers France
Hôpital des Enfants Bordeaux Bordeaux France
CHU Grenoble Grenoble France
Hôpital Femme-Mère-Enfant Lyon Lyon France
CHRU Nantes Nantes France
Hôpital Necker Paris France
Hôpital Trousseau Paris France
CHRU Rennes Rennes France
Centre de Perharidy Roscoff France
Hôpital Charles Nicolle Rouen France
CHRU de Tours Tours France

More University Hospital, Brest trials in France

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03947957 on ClinicalTrials.gov ↗ ← All trials in France