Assessing the Performance of Shotgun Metagenomics in the Diagnosis of Complex Prosthetic Joint In… (NCT06062251) | Clinical Trial Compass
CompletedNot Applicable
Assessing the Performance of Shotgun Metagenomics in the Diagnosis of Complex Prosthetic Joint Infections
France144 participantsStarted 2024-02-27
Plain-language summary
The objectiveof this of a prospective, multicentre study is to evaluate the performance of shotgun metagenomics in the diagnosis of chronic Prosthetic joint infection (PJI) in comparison with the adapted MSIS diagnostic score..
The main questions it aims to answer are:
* To evaluate the performance of shotgun metagenomics in the diagnosis of chronic PJI in comparison with culture.
* To describe the epidemiology of bacterial species responsible for chronic PJI in Western France and their potential resistance to antibiotics.
* Analyzing the diagnostic performance of shotgun culture and metagenomics as a function of potentially administered antibiotic treatments A total of 143 patients sampled will be included. Six intraoperative samples will be taken for each patient, as part of routine care. In addition to the standard preoperative check-up, an extra volume of blood will be taken for CRP measurement at inclusion.
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:
* Male or female ≥ 18 years
* Patients being considered for surgery for suspected chronic PJI (time between joint replacement surgery and patient inclusion \> 3 months)
* Social security affiliation
* No objection to participating in the study
Exclusion Criteria:
* Suspicion or documentation (positive blood cultures) of acute bacteremia at time of inclusion
* Patients under guardianship or trusteeship
* Pregnant or breastfeeding woman
* Patient deprived of liberty by legal or administrative decision
* Patients in psychiatric care
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
PJI diagnosis
Timeframe: from samples taken during surgery. Shotgun metagenomics will be performed at the end of the inclusion of all patients, i.e. one year after the start of the study