InfectionMETADIAG 2NCT07256405
Metagenomic Next-Generation Sequencing for the Diagnosis of Fracture-related Infection
An observational study of Infection and Fracture, run by Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer at 2 sites in France.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Metagenomic sequencing
- How many people
- 100 participants
- Where
- 2 sitesFrance
- Study dates
- 11 Mar 2024to 31 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients admitted to hospital following trauma for whom a fracture-related infection was diagnosed.
Who may be able to join
- 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
Who cannot join
- Patient opposition
- Patient under a legal protection measure.
Trial locations and contacts
2 sites in 1 country.
France2 sites
IHU, service des maladies infectieuses chroniques
Marseille, Bouches-du-Rhône, 13005
Military Teaching Hospital Sainte Anne
Toulon, VAR, 83000
About this study
Official title: Contribution of Metagenomic Sequencing Using Nanopore Technology to the Management of Post-traumatic Bone and Joint Infections
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.
Read the detailed 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.
- Being tested
- Metagenomic sequencing
- Keywords
- Nanopore, Fracture, Metagenomic, Trauma, Infection, High throughput sequencing
- Medical subject headings
- Infections, Fractures, Bone, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metagenomic sequencingDiagnostic test
Samples shall be submitted to high throughput sequencing using both illumine MiSeq and Oxford Nanopore Technologies.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Diagnostic Test: Metagenomic sequencing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 1 month
Secondary outcomes (3)
Time to obtain final microbiological results by sequencing compared with the reference technique (culture)
Duration (in days) for definitive microbiological diagnosis using both culture and NGS-based protocols.
Measured: 1 month
Number of cases in which an adjustment of targeted antibiotic therapy would be made based on NGS results.
Number of cases in which an adjustment of targeted antibiotic therapy would be made based on NGS results.
Measured: 1 month
Microbial abundance defined by the number of reads (sequence reads) obtained per phylotype
To describe the microbiome of fracture related infection in terms of microbial diversity and abundance in order to discuss both raw reads number and relative abundance roles when considering NGS results in this context.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2025
- Study start11 Mar 2024
- Primary completion31 Dec 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
- Sponsor type
- University, hospital or other
- Collaborators
- Sainte-Anne Military Teaching Hospital, Institut Hospitalo-Universitaire Méditerranée Infection
- Responsible party
- Sponsor
- Investigators
- LACÔTE-DELARBRE David, MD, Study director, Sainte-Anne Military Teaching Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07256405
- Sponsor's protocol ID
- 2023-CHITS-017
- Acronym
- METADIAG 2
- Status last verified
- Jul 2025
- First submitted
- 20 Nov 2025
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 29342065Goswami 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.
PubMed 34887434Sanderson 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.
PubMed 30261842Ivy 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.
PubMed 29848568Walter 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.
PubMed 36143847
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contribution of Metagenomic Sequencing Using Nanopore Technology to the Management of Post-traumatic Bone and Joint Infections
- ClinicalTrials.gov ID
- NCT07256405
- Acronym / sponsor ID
- METADIAG 2 / 2023-CHITS-017
- Keywords
- Nanopore, Fracture, Metagenomic, Trauma, Infection, High throughput sequencing
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Centre Hospitalier Intercommunal de Toulon La Seyne sur MerUniversity, hospital or other
- Collaborators
- Sainte-Anne Military Teaching Hospital, Institut Hospitalo-Universitaire Méditerranée Infection
- Study start
- 11 Mar 2024 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 1 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fracture-related infection | – | Diagnostic Test: Metagenomic sequencingPatients 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted to hospital following trauma for whom a fracture-related infection was diagnosed.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Patient opposition
- Patient under a legal protection measure.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Metagenomic sequencingSamples shall be submitted to high throughput sequencing using both illumine MiSeq and Oxford Nanopore Technologies. | Diagnostic test | Fracture-related infection |
Primary outcome
Concordance between the microbiological documentation obtained by sequencing and that of the reference technique (culture)
Time frame: 1 month
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).
3 secondary outcomes
Time to obtain final microbiological results by sequencing compared with the reference technique (culture)
Time frame: 1 month
Number of cases in which an adjustment of targeted antibiotic therapy would be made based on NGS results.
Time frame: 1 month
Microbial abundance defined by the number of reads (sequence reads) obtained per phylotype
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2026.
- Results publication: PubMed 29342065Tarabichi 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.
- Results publication: PubMed 34887434Goswami 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.
- Results publication: PubMed 30261842Sanderson 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.
- Results publication: PubMed 29848568Ivy 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.
- Results publication: PubMed 36143847Walter 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
LACÔTE-DELARBRE David, MD study director
Sainte-Anne Military Teaching Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infection and Fracture, run by Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concordance between the microbiological documentation obtained by sequencing and that of the reference technique (culture) (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07256405, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2026.