Identifying pathogens in joint infections using advanced molecular techniques
Official title: Molecular Biology (Multiplex PCR) in the Identification of Pathogens at Reimplantation in the Two-Stage Treatment of Periprosthetic Infections (PJI)
Run by IRCCS Azienda Ospedaliero-Universitaria di Bologna · NCT06804265 · Data updated 2026-11-12
This study is testing a new method called Multiplex PCR to see if it can better identify germs causing joint infections compared to the usual lab tests.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | IRCCS Azienda Ospedaliero-Universitaria di Bologna Academic / other |
| Locations | 1 site (Bologna) |
| Status | Recruiting |
| Started | January 7, 2025 |
| Main results expected | April 30, 2028 |
| Study ends | April 30, 2028 |
| Registry record updated | February 3, 2025 |
| Trial ID | NCT06804265 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 and older diagnosed with periprosthetic infections of the hip, knee, or shoulder who are undergoing treatment with a two-stage protocol.
✕Probably not a fit
Patients whose infection isolates are not included in the Multiplex PCR panel will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to evaluate the diagnostic accuracy of the Multiplex PCR technique for identifying pathogens during the treatment of periprosthetic joint infections (PJIs) using a two-stage protocol. It will compare the results from Multiplex PCR with standard culture examinations to determine the effectiveness of this molecular approach. Data collected will include patient demographics, surgical details, and outcomes related to infection resolution and reimplantation. The study will also document complications and the clinical status of patients post-treatment.
Why it matters
Potential benefit: If successful, this study could enhance the accuracy of pathogen identification in PJIs, leading to improved treatment outcomes.
How similar studies have gone: While the use of Multiplex PCR in pathogen identification is gaining traction, this specific application in PJIs is relatively novel and has not been extensively tested in prior studies.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Diagnosis of periprosthetic infection of hip, knee, shoulder on primary or already revised implant. * treatment of infection with two-stage protocol. * Obtaining informed consent * Age ≥18 years Exclusion Criteria: * Isolates obtained during explantation not included in MULTIPLEX PCR panel
Where it's running
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IRCCS Azienda Ospedaliero-Universitaria di Bologna
Bologna, Italy Recruiting
Study contacts
- Principal investigator: Massimiliano - De Paolis, MD — IRCCS Azienda Ospedaliero-Universitaria di Bologna
- Study coordinator: Massimiliano De Paolis, MD
- Email: massimiliano.depaolis@aosp.bo.it
- Phone: 0512144332
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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.