Metagenomic Next-Generation Sequencing for the Diagnosis of Fracture-related Infection (METADIAG 2)

Intermunicipal Hospital Center Toulon

Status: Active, not recruiting

Conditions: Infection; Fracture; Bone

Treatments: Diagnostic Test: Metagenomic sequencing

Study type: Observational

Funder types: Other

Identifiers

NCT07256405

2023-CHITS-017

Details and patient eligibility

About

The value of next-generation sequencing (NGS) using Nanopore technology has been demonstrated in the case of diabetic patients' wounds or in prosthetic joint infections. The aim of this study is to demonstrate its relevance as a new diagnostic approach for fracture-related infections (FRI).

Bone samples from patient with FRI will be submitted to shotgun metagenomic Next-generation sequencing using Oxford Nanopore Technology (ONT) in order to establish its diagnostic value in this context in comparison with the reference method.

Full description

Tissue samples from patients with FRI used for routine culture and remaining after this step will be retrieved for metagenomic sequencing.

Both DNA extraction and host-DNA depletion steps will be performed. The nanopore ligation sequencing protocol along with native barcoding will be used to carry out DNA library preparation. Sequencing will be run using ONT GridION device. The generated reads will be computerized to be assigned at each taxonomic levels. The results will be compared to those of routine diagnosis to determine NGS concordance with culture.

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age ≥ 18 years
• Diagnosis of fracture-related infection (FRI consensus group)
• Patient scheduled to undergo a bone and/or soft-tissue biopsy as part of routine care

Exclusion criteria

• Patient opposition
• Patient under a legal protection measure.

Trial design

100 participants in 1 patient group

Fracture-related infection

Description:

Patients suspected of having acute or chronic post-traumatic osteoarticular infection according to the criteria of the FRI (Fracture-Related Infection) consensus group and scheduled to undergo a bone and/or soft tissue biopsy as part of routine care

Treatment:

Diagnostic Test: Metagenomic sequencing