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Completed

NCT Number: NCT05770856

Clinical Metagenomic of Post-traumatic Infections

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.

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Key information

Conditions

Fractures, Bone Disease Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Military Teaching Hospital Sainte Anne

Toulon, Var, 83000, France

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Metagenomic sequencing

Diagnostic Test

Samples shall be submitted to high throughput sequencing using both illumine MiSeq and Oxford Nanopore Technologies.

Primary outcomes

  1. Microbiome of fracture-related and other trauma-related infection

    Time frame: About 2 months

    Metagenomic sequencing will be used to determine the microbiome of trauma-related infections using Illumina MiSeq and Oxford Nanopore Technologies.

    Data will be compared with those from reference microbiological identification techniques (culture).

Secondary outcomes

  1. Comparison of high throughput sequencing techniques yield

    Time frame: About 3 months

    The FRI-associated microbiomes composition obtained with each sequencing methods will be compared in terms of abundance and variety (K coefficient and frequency)

  2. Number and nature of virulence or resistance factors among identified OTU (operational Taxonomic Unit)

    Time frame: About 6 months

    Functional annotation of sequenced bacterial genomes to assess the presence of virulence and/or resistance-associated factors, using Prokka software.

  3. Number of bacteria and their relative abundance according to patients' outcome using the EBJIS (European Bone and Joint Infection) definition

    Time frame: About 6 months

    To determine the association of the NGS-based microbiome longtitudinal composition in terms of variety (number of OTU) and abundance (number of reads) with infection persistence according to the EBJIS (European Bone and Joint Infection) definition.

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer

Other

Collaborators

  • Military Teaching Hospital Sainte Anne, Toulon
  • UMR Vitrome, IRD 257

Registry information

Official study title

Clinical Metagenomic Next-Generation Sequencing for Microbial Infections in Trauma

Acronym: METADIAG

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Mar 16, 2023
Registry last updated
Jul 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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