Invasive Markers of Staphylococcus Epidermidis (NCT03374371) | Clinical Trial Compass
CompletedNot Applicable
Invasive Markers of Staphylococcus Epidermidis
France320 participantsStarted 2018-03-01
Plain-language summary
The purpose of the study is to identify biomarkers allowing the distinction between invasive and non-invasive strains of Staphylococcus epidermidis. This distinction is important to determine if the patient is infected and, as a consequence, if an antibiotic treatment is required.
Who can participate
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
. Hospitalized patient with intravascular device (peripheral or central, venous or arterial, short or long duration) for at least 48 hours before the development of bacteraemia
. Presenting a definite infection with S. epidermidis according to the categorization criteria,
. An operated patient carrying implanted equipment following orthopaedic surgery, following cardiac surgery or following neurosurgery,
. Presenting a definite infection with S. epidermidis according to the categorization criteria occurring in the year following surgery
. Hospitalized patient with intravascular device (peripheral or central, venous or arterial, short or long duration) for at least 48 hours before positive blood culture with S. epidermidis
. Certain contamination with S. epidermidis according to the categorization criteria,
. An operated patient carrying implanted equipment following orthopedic surgery, following cardiac surgery or following neurosurgery,
. Presenting a certain contamination to S. epidermidis according to the categorization criteria occurring in the year following surgery
Exclusion criteria
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
1
genetic markers of S. epidermidis
Timeframe: at the time of the positive sampling of S. epidermidis
. Opposition of the patient or the holders of parental authority (minor patients)
. Patient with polymicrobial infection
. Patient with a colonized catheter (positive catheter end culture \<103UFC / mL) with no clinical signs of local or general infection and with sterile peripheral blood cultures
. Patient with local catheter infection (positive catheter end culture\> 103UFC / mL) with local inflammatory signs only and with sterile peripheral blood cultures
. Opposition of the patient or the holders of parental authority (minor patients)
. Patient with an infection of material concomitant with a catheter-related infection