One-stage prosthesis exchange for Candida joint infections
One-stage Exchange in Candida Periprosthetic Infection a Suitable Way to go
This project tests whether replacing an infected hip or knee prosthesis in a single operation helps adults with Candida joint infections.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 16 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Strasbourg, France Academic / other |
| Locations | 1 site (Strasbourg) |
| Trial ID | NCT07303101 on ClinicalTrials.gov |
What this trial studies
This is a retrospective observational analysis of adults who underwent hip or knee prosthesis revision at Strasbourg University Hospitals between January 1, 2013 and December 31, 2021 with possible or proven Candida periprosthetic infection according to EBJIS criteria. Included patients are over 18, had at least three deep microbiologic samples (joint fluid, preoperative tissue, or prosthesis sonication), and received systemic antifungal treatment after implant exchange. The analysis describes outcomes after one-stage prosthesis exchange and compares observed success rates with those reported for two-stage replacement in the literature. Systemic antifungal regimens and surgical details are recorded but expected to be heterogeneous, and prior evidence is limited to small retrospective series.
Who should consider this trial
Good fit: Ideal candidates are adults (>18) who had hip or knee prosthesis revision at CHU Strasbourg between 2013 and 2021 with possible or proven Candida periprosthetic infection (EBJIS criteria), at least three deep samples, and who received systemic antifungal therapy.
Not a fit: Patients managed with implant retention (lavage/synovectomy), those with concurrent Candida infections elsewhere or endocarditis, patients on suppressive antifungal therapy before surgery, or those who did not receive systemic antifungals are unlikely to benefit from one-stage exchange in this analysis.
Why it matters
Potential benefit: If successful, this approach could allow some patients to be cured with a single operation, reducing recovery time, hospital stays, and overall treatment burden.
How similar studies have performed: Only three small retrospective single-center reports have examined one-stage exchange for Candida periprosthetic infection, reporting 2-year success rates around 63–81% that are similar to ranges reported for two-stage replacement, but overall evidence remains limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patient aged over 18 years at the time of prosthesis revision * Operated on at the Strasbourg University Hospitals (HUS) between January 1, 2013, and December 31, 2021 * Hip or knee prosthesis revision * Possible or proven periprosthetic Candida spp. infection according to the EBJIS diagnostic criteria * Minimum of 3 deep samples (joint fluid, preoperative sample, and/or prosthesis sonication) Exclusion Criteria: * Patient undergoing lavage, synovectomy, and implant preservation * Patient not receiving systemic antifungal treatment after prosthesis replacement * Patient with another proven Candida spp. infection or infective endocarditis * Patient for whom suppressive therapy was prescribed prior to surgery.
Where this trial is running
Strasbourg
- Service de Chirurgie Orthopédique Septique - CHU de Strasbourg - France — Strasbourg, France (Recruiting)
Study contacts
- Study coordinator: Stéphane Klein, MD
- Email: stephane.klein@chru-strasbourg.fr
- Phone: 33 3 68 76 52 32
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.