SuspendedNot Applicable

OsteoArticular Sepsis in Intensive Care unitS

Stopped: Temporary suspended. Wait for IRB approval (inclusion duration modified)

France150 participantsStarted 2025-03-31

Plain-language summary

This is an ambispective observational study of patients admitted to intensive care with a diagnosis of joint prosthesis infection (mainly knee and hip prostheses). The main objective of the study is to describe the profile, care trajectories during the stay (before or after surgery) and prognosis of patients admitted to critical care with such an infection. We also aim to compare prognosis between different groups of patients sharing the same profile and care trajectory, and to assess independent risk factors associated with 2-year mortality among the study population. Finally, we will describe the microbiological and resistance profile of severe osteoarticular device infections requiring critical care admission in France. This is a descriptive and analytical observational study open to all French public and private hospitals. Patient data will be retrieved prospectively from patient source files. Only 2-year data (vital status, functional data) will be collected specifically for the study, by telephone contact with the patient or his or her support person.

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: * Patient at least 18 years old. * Hospitalization in critical care (intensive care unit or continuing care unit) between 2018 and 2022 of at least 48 hours, with prosthetic joint infection (hip, knee or shoulder prosthesis infection) as the main or associated diagnosis. Exclusion Criteria: * Infection on osteosynthesis material * Infection on spinal equipment * Patient with several infected prostheses * Recurrence of infection on prosthesis with the same microorganism * Patient opposing data collection * Patient under legal protection. * Pregnant or breast-feeding patient. * Patient deprived of liberty.

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

The profile, trajectories of care during the stay (before or after surgery) and the prognosis of patients admitted to intensive care for joint prosthesis infection over a 2-year period after admission to intensive care.

Timeframe: 2 years

Trial details

NCT IDNCT06627842

SponsorAssistance Publique - Hôpitaux de Paris

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2026-10-01

View on ClinicalTrials.gov More Osteoarticular Infection trials