UnknownNot Applicable

Cutaneous Microbiota Evolution in ICU Patients With CVC (ICMc)

French Guiana120 participantsStarted 2023-06-02

Plain-language summary

Intensive Care Unit (ICU) patients are exposed to catheter-related infections with an important morbidity. Catheter colonization is constant but infection is not. Cutaneous dysbiosis could be the missing link. Our study aims to evaluate the evolution of cutaneous microbiota in ICU patients with a central venous catheter in place, through metagenomics. Our main objective is to evaluate the evolution of alpha-diversity, quantified by intra-patient variation of Shannon diversity index (a diversity index used in bacterial metagenomics).

Who can participate

Age range

18 Years

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: \- Adult hospitalized in ICU at the Cayenne Hospital Center in whom the installation of a CVC is indicated Exclusion Criteria: * Patient under 18 years of age * Patient or trusted person or family or relative objecting to participation in the study (refusal) * Patient under judicial safeguard or under any other protective regime (guardianship or curatorship) * Patient with cutaneous lesions (infection, burn) near the cutaneous insertion site of the CVC

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

Evolution of alpha-diversity

Timeframe: Baseline

Evolution of alpha-diversity

Timeframe: Day 3

Trial details

NCT IDNCT06095076

SponsorCentre Hospitalier de Cayenne

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2023-12-02

Contact for this trial

Ariane ROUJANSKY

+594594395354 ariane.roujansky@ch-cayenne.fr

View on ClinicalTrials.gov More Dysbiosis trials