One-stage Exchange in Candida Periprosthetic Infection a Suitable Way to go
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Candida Infection. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Primary outcome measures
- Candida spp. infection eradication rate [Time frame: for the duration of hospital stay, up to 1 year]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
France · 1 center
- Service de Chirurgie Orthopédique Septique - CHU de Strasbourg - France — Strasbourg
Identifiers
NCT: NCT07303101 · 9477