Treatment of the Infections on Osteo-articular Prostheses by 6 Versus 12 Weeks of Antibiotherapy (NCT01816009) | Clinical Trial Compass
CompletedPhase 3
Treatment of the Infections on Osteo-articular Prostheses by 6 Versus 12 Weeks of Antibiotherapy
France410 participantsStarted 2011-11
Plain-language summary
The study is a prospective, open randomized, non-inferiority trial with two parallel groups, comparing 6 weeks versus 12 weeks of antibiotic treatment following surgery procedure (debridement and retention, 1-stage or 2 stage exchange).
The duration of the treatment antibiotic of prosthetic joint infections is only based on experts' opinion ; this one varies from 6 weeks to several months according to the customs of the influencer.
The principal aim of this study is to explore the efficacy and safety of 6 weeks versus 12 weeks antibiotic therapy duration, both associated with surgical procedure (debridement and retention of implant, one-stage or two stages exchange), in PJI treatment.
The study concerns 410 men or women of more than 18 years include in 34 centres in France.
The duration of the study is of 4 years.
Who can participate
Age range
18 Years – 99 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:
* Men or women over 18, presenting at least one of the following clinical signs: pain, fever, dent or flow of scar
* Bacterial infection on osteo-articular prosthesis (hip or knee)
* Documented basterial infection
* Surgical care optimized with prothesis change or articular washing
* Infection requiring an antibiotic treatment by parenteral way Intravenous injection or per bone
* Treatment effective antibiotic begun in the most previously 21 days
* Signed consent
Exclusion Criteria:
* Patient with no proof of osteo-articular infection
* No surgical care
* Patient having more than one prothesis change because of sepsis
* Infection due to mycobactery, fungic infection or brucellienne infection
* Patient with life expectancy supposed lower than 2 years
* Guardianship patient
* Patient included in another 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.
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.