Evaluating a new method for diagnosing complex joint infections
Assessing the Performance of Shotgun Metagenomics in the Diagnosis of Complex Prosthetic Joint Infections (METAGENOS)
University Hospital, Brest · NCT06062251
This study is testing a new way to diagnose complex joint infections in patients with prosthetic joints to see if it works better than the usual methods.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 143 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Brest (other) |
| Locations | 1 site (Brest) |
| Trial ID | NCT06062251 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the effectiveness of shotgun metagenomics in diagnosing chronic prosthetic joint infections (PJI) compared to traditional culture methods. It will involve a total of 143 patients, with six intraoperative samples collected from each participant as part of routine care. The study will also analyze the epidemiology of bacterial species causing chronic PJI in Western France and their antibiotic resistance patterns. Additionally, it will evaluate the diagnostic performance of shotgun metagenomics in relation to antibiotic treatments administered prior to sampling.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who are scheduled for surgery due to suspected chronic prosthetic joint infections.
Not a fit: Patients with acute bacteremia or those who are pregnant, breastfeeding, or under legal guardianship will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more accurate and timely diagnoses of chronic prosthetic joint infections, improving patient outcomes.
How similar studies have performed: While the use of shotgun metagenomics is a relatively novel approach in this context, similar studies have shown promise in improving diagnostic accuracy for infectious diseases.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Brest
- Brest university hospital — Brest, France (RECRUITING)
Study contacts
- Principal investigator: Rachel CHENOUARD, Dr — Angers HU
- Study coordinator: claudi LAMOUREUX, Dr
- Email: claudie.lamoureux@chu-brest.fr
- Phone: 02.21.74.31.84
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Prosthetic Joint Infection, Prosthetic joint infection, microbiological diagnosis, shotgun metagenomics