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 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.
1Since this study is actively following children but no longer enrolling new participants, is there any similar observational study still recruiting that my child might be considered for?
2This trial is tracking whether Pseudomonas aeruginosa shows up in sputum cultures by the time a child is 36 months old — how does early Pseudomonas colonization typically affect my child's long-term lung health, and should we already be monitoring for it regardless of any study?
3Because this is an observational study rather than a treatment trial, what would my child actually be asked to do, and how does that kind of regular sputum collection fit into what you'd recommend for their routine cystic fibrosis care anyway?
4The study is looking at microbial biomarkers as early warning signs of Pseudomonas — are there any current clinical tools or tests you're already using to watch for early bacterial colonization in my child's airways?
5If this study identifies biomarkers that predict early Pseudomonas colonization, how might those findings eventually change the way doctors like you approach prevention or treatment decisions for young children with cystic fibrosis?
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
1
Presence of P. aeruginosa in bacterial sputum cultures collected at 36 months of age