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Clinical Metagenomic of Post-traumatic Infections (METADIAG)

I

Intermunicipal Hospital Center Toulon

Status

Completed

Conditions

Infections
Fractures, Bone

Treatments

Diagnostic Test: Metagenomic sequencing

Study type

Observational

Funder types

Other

Identifiers

NCT05770856
2023-CHITS-003

Details and patient eligibility

About

Treatment of fracture related infection is challenging and often lead to failure in such situation that carry a high health cost burden.

These infections are often polymicrobial, making the identification of all involved microorganisms a major concern to provide tailored antibiotic treatment. Culture-independent methods are needed to better represent the microbial diversity of infected wounds. Metagenomic sequencing might lead to an accurate microbiome characterization in infected trauma-related wound.

Preliminary studies have reported results of metagenomic sequencing in diabetic foot infection but data focusing on non-diabetic infected patients are scarce.

The impact of post-traumatic infected wound microbiome needs to be assessed, with regards to bacterial abundance, diversity including at the strain level and functional genes, along with their longitudinal evolution and association with clinical outcomes.

Full description

DNA will be extracted from samples carried out during surgical procedures. Different extraction protocols will be assessed to determine the best to be used for this type of tissue samples.

Purified DNA will be quantified using the Qubit dsDNA High-Sensitivity Assay Kit (Invitrogen). The quality of the fragment length will be estimated with the DNA high-sensitivity kit in the 2100 Bioanalyzer (Agilent Technologies). DNA sequencing will be performed with Oxford Nanopore Technologie devices: MinIONTM and GridIONTM.

Another sequencing of the same samples will be performed on the MiSeq after libraries preparation using the NexteraXT DNA Library Preparation Kit (Illumina).

Sequenced OTU from both sequencing methods will be confronted at different taxonomic ranks and compared with conventional routine method results (bacterial culture). A functional analysis of sequences will be done to identify potential genes associated with clinical outcome.

Enrollment

25 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Age ≥ 18 years
  • Diagnosis of trauma-related infection

Exclusion criteria

  • Participation in an interventional research during the study
  • Patient opposition
  • Absence of bone or soft tissue samples stored at -80°C

Trial design

25 participants in 1 patient group

Trauma related infection
Treatment:
Diagnostic Test: Metagenomic sequencing

Trial contacts and locations

1

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Central trial contact

Asmaa JOBIC

Data sourced from clinicaltrials.gov

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