NCT07303101 One-stage Exchange in Candida Periprosthetic Infection a Suitable Way to go
| NCT ID | NCT07303101 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Strasbourg, France |
| Condition | Candida Infection |
| Study Type | OBSERVATIONAL |
| Enrollment | 16 participants |
| Start Date | 2025-05-28 |
| Primary Completion | 2026-02 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 16 participants in total. It began in 2025-05-28 with a primary completion date of 2026-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07303101 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Candida Infection. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07303101 currently recruiting?
Yes, NCT07303101 is actively recruiting participants. Contact the research team at stephane.klein@chru-strasbourg.fr for enrollment information.
Where is the NCT07303101 trial being conducted?
This trial is being conducted at Strasbourg, France.
Who is sponsoring the NCT07303101 clinical trial?
NCT07303101 is sponsored by University Hospital, Strasbourg, France. The trial plans to enroll 16 participants.