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 range

2 Months – 6 Months

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Presence of P. aeruginosa in bacterial sputum cultures collected at 36 months of age

Timeframe: 36 months

Trial details

NCT IDNCT03947957

SponsorUniversity Hospital, Brest

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-11

View on ClinicalTrials.gov More Cystic Fibrosis trials

Who can participate

Age range

2 Months – 6 Months

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.