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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

16 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-05-28

Study Completion Date

2026-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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Candida Infection

Keywords

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Candida infection Prosthesis replacement

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Locations

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Service de Chirurgie Orthopédique Septique - CHU de Strasbourg - France

Strasbourg, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Stéphane Klein, MD

Role: CONTACT

Phone: 33 3 68 76 52 32

Email: [email protected]

Facility Contacts

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Sté Klein, MD

Role: primary

Other Identifiers

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9477

Identifier Type: -

Identifier Source: org_study_id