Actively Recruiting
Assessing the Performance of Shotgun Metagenomics in the Diagnosis of Complex Prosthetic Joint Infections (METAGENOS)
Led by University Hospital, Brest · Updated on 2025-02-05
143
Participants Needed
1
Research Sites
39 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the use of shotgun metagenomics to diagnose chronic Prosthetic Joint Infection (PJI) compared to the adapted Musculoskeletal Infection Society (MSIS) diagnostic score and culture methods. PJI is a serious complication after joint replacement surgery that can lead to disability and increased health risks. The study aims to improve diagnosis by identifying the bacteria causing infection and their antibiotic resistance, helping guide better treatment decisions. This observational study involves collecting six intraoperative samples from each of 143 patients suspected of chronic PJI during surgery. In addition to routine tests, an extra blood sample will be taken for C-reactive protein (CRP) measurement. Shotgun metagenomics sequencing will be performed after all patient inclusions are complete, approximately one year after the study starts, to assess its diagnostic performance alongside standard culture methods. Participants will undergo preoperative check-ups and surgery with sample collection for microbiological analyses. Researchers will monitor bacterial presence, antibiotic resistance, and diagnostic accuracy using several outcome measures. The study will also examine the impact of prior antibiotic treatments on diagnosis. The total involvement duration includes the surgical period and one year of follow-up for metagenomics analysis and data review.
CONDITIONS
Brief Title
Assessing the Performance of Shotgun Metagenomics in the Diagnosis of Complex Prosthetic Joint Infections
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 18 years or older
- Patients considered for surgery for suspected chronic prosthetic joint infection (more than 3 months after joint replacement surgery)
- Affiliated with social security
- No objection to participating in the study
You will not qualify if you...
- Suspected or documented acute bloodstream infection at time of inclusion
- Under legal guardianship or trusteeship
- Pregnant or breastfeeding women
- Deprived of liberty by legal or administrative decision
- Currently receiving psychiatric care
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of surgery
During surgery for suspected chronic prosthetic joint infection, multiple intraoperative samples are collected to diagnose infection using culture and later shotgun metagenomics.
1 surgical visit
Duration - Usually within 3 to 15 days following surgery
Participants are monitored in the immediate post-operative period for antibiotic resistance and sensitivity testing and recovery.
Approximately 1 follow-up visit
Duration - Up to 1 year after surgery
Participants are observed as shotgun metagenomics analysis is performed on collected samples about one year after study start to assess diagnostic performance.
Visit schedule varies
Trial Site Locations
Total: 1 location
1
Brest university hospital
Brest, France, 29200
Actively Recruiting
Research Team
C
claudi LAMOUREUX, Dr
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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