Assessing the Performance of Shotgun Metagenomics in the Diagnosis of Complex Prosthetic Joint Infections

NCT06062251 | Recruiting

• 1 other identifier: 29BRC22.0208
• Study Type: observational
• Target: 143
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Prosthetic Joint Infection

Keywords

Prosthetic joint infection; microbiological diagnosis; shotgun metagenomics

Outcome Measures

Primary Outcomes (1)

• PJI diagnosis

  PJI diagnosis (positive/negative) obtained by shotgun metagenomics and by the adapted MSIS criteria (gold standard)MSIS diagnostic score (gold standard).

  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

Secondary Outcomes (4)

• PJI diagnosis (positive/negative) obtained by shotgun metagenomics and by culture

  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

• Presence/absence of a bacterial species (by culture and/or shotgun metagenomics) in a patient sample considered infected according to the appropriate MSIS score

  : 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

• Resistance/sensitivity to antibiotics tested

  immediate post-operative period (usually within 3-15 days following surgery)

• PJI diagnosis (positive/negative) obtained by shotgun metagenomics and by culture in case of presence/absence of antibiotic therapy the month before surgery

  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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with suspected chronic prosthetic joint infection

You may qualify if:

• Male or female ≥ 18 years
• Social security affiliation
• No objection to participating in the study

You may not qualify if:

• Patients under guardianship or trusteeship
• Pregnant or breastfeeding woman
• Patient deprived of liberty by legal or administrative decision
• Patients in psychiatric care

Sponsors & Collaborators

• University Hospital, Brest: lead

Study Sites (1)

Brest university hospital

Brest, 29200, France

RECRUITING

Study Officials

• Rachel CHENOUARD, Dr

  Angers HU

  PRINCIPAL INVESTIGATOR

• Stéphane CORVEC, PhD

  Nantes HU

  PRINCIPAL INVESTIGATOR

• Chloé PLOUZEAU, Dr

  Poitier HU

  PRINCIPAL INVESTIGATOR

• Sophie REISSIER, Dr

  Rennes HU

  PRINCIPAL INVESTIGATOR

• Marie-Frédérique LARTIGUE, Dr

  Tours HU

  PRINCIPAL INVESTIGATOR

Central Study Contacts

claudi LAMOUREUX, Dr

CONTACT

02.21.74.31.84; claudie.lamoureux@chu-brest.fr

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2023
• First Posted: October 2, 2023
• Study Start: February 27, 2024
• Primary Completion: September 1, 2025
• Study Completion (Estimated): June 1, 2026
• Last Updated: February 5, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: All collected data that underlie results in a publication
• Access Criteria: Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement.

Locations

FR (1)