Clinical Metagenomic of Post-traumatic Infections

NCT05770856 | Completed

• 1 other identifier: 2023-CHITS-003
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Fractures, Bone; Infections

Keywords

High throughput sequencing; Nanopore; Diagnosis; Trauma; Microbiome; Infection

Outcome Measures

Primary Outcomes (1)

• Microbiome of fracture-related and other trauma-related infection

  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).

  About 2 months

Secondary Outcomes (3)

• Comparison of high throughput sequencing techniques yield

  About 3 months

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

  About 6 months

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

  About 6 months

Study Arms (1)

Trauma related infection

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.

Trauma related infection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients admitted to hospital for trauma for which an infection of the traumatic site was diagnosed

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer: lead
• Military Teaching Hospital Sainte Anne, Toulon: collaborator
• UMR Vitrome, IRD 257: collaborator

Study Sites (1)

Military Teaching Hospital Sainte Anne

Toulon, Var, 83000, France

Location

Related Publications (5)

• 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 BACKGROUND

• Jnana A, Muthuraman V, Varghese VK, Chakrabarty S, Murali TS, Ramachandra L, Shenoy KR, Rodrigues GS, Prasad SS, Dendukuri D, Morschhauser A, Nestler J, Peter H, Bier FF, Satyamoorthy K. Microbial Community Distribution and Core Microbiome in Successive Wound Grades of Individuals with Diabetic Foot Ulcers. Appl Environ Microbiol. 2020 Mar 2;86(6):e02608-19. doi: 10.1128/AEM.02608-19. Print 2020 Mar 2.

  PMID: 31924616 BACKGROUND

• Kalan LR, Meisel JS, Loesche MA, Horwinski J, Soaita I, Chen X, Uberoi A, Gardner SE, Grice EA. Strain- and Species-Level Variation in the Microbiome of Diabetic Wounds Is Associated with Clinical Outcomes and Therapeutic Efficacy. Cell Host Microbe. 2019 May 8;25(5):641-655.e5. doi: 10.1016/j.chom.2019.03.006. Epub 2019 Apr 18.

  PMID: 31006638 BACKGROUND

• Mudrik-Zohar H, Carasso S, Gefen T, Zalmanovich A, Katzir M, Cohen Y, Paitan Y, Geva-Zatorsky N, Chowers M. Microbiome Characterization of Infected Diabetic Foot Ulcers in Association With Clinical Outcomes: Traditional Cultures Versus Molecular Sequencing Methods. Front Cell Infect Microbiol. 2022 Mar 24;12:836699. doi: 10.3389/fcimb.2022.836699. eCollection 2022.

  PMID: 35402307 BACKGROUND

• Delarbre D, Lavrard P, Elias A, Bossi V, Kacel I, Janvier F, Fournier PE. Bacterial DNA enrichment for low-inoculum fracture-related infection diagnostic using high-throughput sequencing. Diagn Microbiol Infect Dis. 2024 Sep;110(1):116411. doi: 10.1016/j.diagmicrobio.2024.116411. Epub 2024 Jun 22.

  PMID: 39018934 RESULT

Biospecimen

Retention: SAMPLES WITH DNA

Surgical bone and soft tissue samples

MeSH Terms

Conditions

Fractures, Bone; Infections; Disease; Wounds and Injuries

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• David LACÔTE-DELARBRE, MD

  Military Teaching Hospital Sainte Anne

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: February 7, 2023
• First Posted: March 16, 2023
• Study Start: April 27, 2023
• Primary Completion: July 15, 2023
• Study Completion: July 15, 2023
• Last Updated: July 29, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)