Metagenomic Next-Generation Sequencing for the Diagnosis of Fracture-related Infection

NCT07256405 | Active Not Recruiting

• 1 other identifier: 2023-CHITS-017
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Infection; Fracture; Bone

Keywords

Nanopore; Fracture; Metagenomic; Trauma; Infection; High throughput sequencing

Outcome Measures

Primary Outcomes (1)

• Concordance between the microbiological documentation obtained by sequencing and that of the reference technique (culture)

  Metagenomic sequencing will be used to determine the microbiome of fracture-related infections. Data will be compared with those of reference microbiological identification techniques (culture).

  1 month

Secondary Outcomes (3)

• Time to obtain final microbiological results by sequencing compared with the reference technique (culture)

  1 month

• Number of cases in which an adjustment of targeted antibiotic therapy would be made based on NGS results.

  1 month

• Microbial abundance defined by the number of reads (sequence reads) obtained per phylotype

  1 month

Study Arms (1)

Fracture-related infection

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

Diagnostic Test: Metagenomic sequencing

Interventions

Metagenomic sequencing DIAGNOSTIC_TEST

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

Fracture-related infection

Eligibility Criteria

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

Study Population

Patients admitted to hospital following trauma for whom a fracture-related infection was diagnosed.

You may qualify if:

• 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

You may not qualify if:

• Patient opposition
• Patient under a legal protection measure.

Sponsors & Collaborators

• Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer: lead
• Military Teaching Hospital Sainte Anne, Toulon: collaborator
• Institut Hospitalo-Universitaire Méditerranée Infection: collaborator

Study Sites (2)

IHU, service des maladies infectieuses chroniques

Marseille, Bouches-du-Rhône, 13005, France

Location

Military Teaching Hospital Sainte Anne

Toulon, VAR, 83000, France

Location

Related Publications (5)

• Tarabichi M, Shohat N, Goswami K, Alvand A, Silibovsky R, Belden K, Parvizi J. Diagnosis of Periprosthetic Joint Infection: The Potential of Next-Generation Sequencing. J Bone Joint Surg Am. 2018 Jan 17;100(2):147-154. doi: 10.2106/JBJS.17.00434.

  PMID: 29342065 RESULT

• Goswami K, Shope AJ, Tokarev V, Wright JR, Unverdorben LV, Ly T, Chen See J, McLimans CJ, Wong HT, Lock L, Clarkson S, Parvizi J, Lamendella R. Comparative meta-omics for identifying pathogens associated with prosthetic joint infection. Sci Rep. 2021 Dec 9;11(1):23749. doi: 10.1038/s41598-021-02505-7.

  PMID: 34887434 RESULT

• Sanderson ND, Street TL, Foster D, Swann J, Atkins BL, Brent AJ, McNally MA, Oakley S, Taylor A, Peto TEA, Crook DW, Eyre DW. Real-time analysis of nanopore-based metagenomic sequencing from infected orthopaedic devices. BMC Genomics. 2018 Sep 27;19(1):714. doi: 10.1186/s12864-018-5094-y.

  PMID: 30261842 RESULT

• Ivy MI, Thoendel MJ, Jeraldo PR, Greenwood-Quaintance KE, Hanssen AD, Abdel MP, Chia N, Yao JZ, Tande AJ, Mandrekar JN, Patel R. Direct Detection and Identification of Prosthetic Joint Infection Pathogens in Synovial Fluid by Metagenomic Shotgun Sequencing. J Clin Microbiol. 2018 Aug 27;56(9):e00402-18. doi: 10.1128/JCM.00402-18. Print 2018 Sep.

  PMID: 29848568 RESULT

• Walter N, Orbenes N, Rupp M, Alt V. The State of Research in Fracture-Related Infection-A Bibliometric Analysis. Medicina (Kaunas). 2022 Aug 29;58(9):1170. doi: 10.3390/medicina58091170.

  PMID: 36143847 RESULT

Biospecimen

Retention: SAMPLES WITH DNA

tissue samples

MeSH Terms

Conditions

Infections; Fractures, Bone; Wounds and Injuries

Study Officials

• LACÔTE-DELARBRE David, MD

  Military Teaching Hospital Sainte Anne

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: November 20, 2025
• First Posted: December 1, 2025
• Study Start: March 11, 2024
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: December 5, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)