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Recruiting Observational

One-stage Exchange in Candida Periprosthetic Infection a Suitable Way to go

NCT07303101 · tracked via the Priya Life Science France tracker
Phase
Observational
Started
2025-05-28
Last updated
2025-12-24

Condition(s) studied

Candida Infection

Study summary

Accounting for only 0.7% to 3% of joint prosthesis infections, yeast infections are considered particularly difficult to treat. They are primarily caused by Candida yeasts, representing over 90% of cases.

Surgical treatment is the cornerstone of managing periprosthetic infections. In cases of chronic bacterial infections, complete implant replacement is necessary and can be performed either in one or two stages.

However, for chronic Candida spp. infections, two-stage prosthesis replacement remains the preferred option. Only three retrospective, single-center studies have evaluated the success rate of one-stage prosthesis replacement in periprosthetic Candida spp. infections in selected patients. Although the sample sizes of these studies are small, the 2-year success rate of 63% to 81% differs little from that of two-stage implant replacement (47% to 100%). Furthermore, systemic antifungal treatment is poorly defined. Recommendations are based on studies with a low level of evidence. The hypothesis is that a single-stage prosthesis replacement combined with appropriate antifungal treatment for chronic periprosthetic Candida spp. infection has the same outcome as a two-stage prosthesis replacement.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Candida spp. infection eradication rate — for the duration of hospital stay, up to 1 year

Trial sites (1)

FacilityCityRegionStatus
Service de Chirurgie Orthopédique Septique - CHU de Strasbourg - France Strasbourg France Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07303101 on ClinicalTrials.gov ↗ ← All trials in France