Microbial Biomarkers of EArly Pseudomonas Aeruginosa Colonization in CHildren With Cystic Fibrosis (NCT03947957) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Microbial Biomarkers of EArly Pseudomonas Aeruginosa Colonization in CHildren With Cystic Fibrosis
France70 participantsStarted 2020-10-02
Plain-language 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.
Who can participate
Age range2 Months – 6 Months
SexALL
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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 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
What they're measuring
1
Presence of P. aeruginosa in bacterial sputum cultures collected at 36 months of age