Biomarkers for Prosthetic Infection Detection using Nanopore Sequencing
Official title: Detection of Biomarkers for Prosthetic Infection Type - (DEBIT)
Run by Portsmouth Hospitals NHS Trust · NCT07838064 · Data updated 2026-11-12
This study tests new biomarkers to rapidly detect prosthetic joint infection in people having hip or knee revision surgery using nanopore sequencing.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 40 (estimated) |
| Sponsor | Portsmouth Hospitals NHS Trust Government |
| Locations | 2 sites (Portsmouth and 1 other locations) |
| Status | Recruiting |
| Started | February 13, 2026 |
| Main results expected | October 31, 2026 |
| Study ends | November 30, 2027 |
| Registry record updated | September 24, 2026 |
| Trial ID | NCT07838064 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults 18 years or older undergoing planned prosthetic revision surgery and able to provide informed consent, with sufficient peri-prosthetic tissue samples collected.
✕Probably not a fit
Patients in whom infection is not detected or who do not show the identified biomarkers may not receive a direct diagnostic benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
The trial aims to identify novel biomarkers for early and accurate diagnosis of prosthetic joint infection (PJI) by analyzing microbial profiles and host immune responses in tissue, synovial fluid, and blood. Samples are collected from patients undergoing revision surgery and compared between infected and non-infected cases using Oxford Nanopore Technologies sequencing. The study will assess whether these biomarkers can improve early diagnosis and guide future treatment strategies, potentially reducing unnecessary antibiotics and helping tailor therapy. Interventions involve prosthetic joint replacement in the surgical context, with analyses conducted across peri-prosthetic tissue and other accessible samples. The study is conducted at Portsmouth Hospitals NHS Trust with collaboration from the University of Portsmouth and participating hospitals in Portsmouth and Southampton.
Why it matters
Potential benefit: If successful, the biomarkers could enable earlier and more accurate PJI diagnosis, leading to better treatment decisions and potentially fewer unnecessary surgeries.
How similar studies have gone: Previous studies in biomarker discovery for PJI have shown promise using molecular profiling, but this approach with nanopore sequencing is relatively novel for PJI.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Male or Female, aged 18 years or above. * Due to undergo prosthetic revision surgery for any reason identified by the clinical team. * Participant is willing and able to give informed consent for participation in the study. * Pre-operative blood samples and at least 5 substantial peri-prosthetic tissue samples of a suitable size to be distributed between labs as outlined were successfully collected (note that it may not be possible to collect synovial fluid in all cases). Exclusion Criteria: * The participant has previously undergone any kind of revision surgery for their hip implant. * The participant has received any antibiotic treatment within the previous two weeks (excluding antibiotics at induction). * Participant lacking capacity to give informed consent. * Any other clinical reason the participant should not be included in the study- at the discretion of the clinical team.
Where it's running
-
Queen Alexandra Hospital
Portsmouth, United Kingdom Recruiting -
Southampton General Hospital
Southampton, United Kingdom Not yet recruiting
Study contacts
- Principal investigator: Samuel Robson — University of Portsmouth
- Study coordinator: Samuel Robson
- Email: samuel.robson@port.ac.uk
- Phone: +442392848484
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.