Identifying pathogens in joint infections using advanced molecular techniques
Molecular Biology (Multiplex PCR) in the Identification of Pathogens at Reimplantation in the Two-Stage Treatment of Periprosthetic Infections (PJI)
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 |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | IRCCS Azienda Ospedaliero-Universitaria di Bologna Academic / other |
| Locations | 1 site (Bologna) |
| Trial ID | NCT06804265 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients whose infection isolates are not included in the Multiplex PCR panel will not benefit from this study.
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 performed: 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.
Eligibility criteria
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 this trial is running
Bologna
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.