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

NCT07303101 | Recruiting

• 1 other identifier: 9477
• Study Type: observational
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Candida Infection

Keywords

Candida infection; Prosthesis replacement

Outcome Measures

Primary Outcomes (1)

• Candida spp. infection eradication rate

  for the duration of hospital stay, up to 1 year

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult subject having hip or knee prosthesis revision

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Strasbourg, France: lead

Study Sites (1)

Service de Chirurgie Orthopédique Septique - CHU de Strasbourg - France

Strasbourg, 67091, France

RECRUITING

MeSH Terms

Conditions

Candidiasis

Condition Hierarchy (Ancestors)

Mycoses; Bacterial Infections and Mycoses; Infections

Central Study Contacts

Stéphane Klein, MD

CONTACT

33 3 68 76 52 32; stephane.klein@chru-strasbourg.fr

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2025
• First Posted: December 24, 2025
• Study Start: May 28, 2025
• Primary Completion: February 1, 2026
• Study Completion: February 1, 2026
• Last Updated: December 24, 2025

Record last verified: 2025-12

Locations

FR (1)