Actively Recruiting

Age: 18Years +
All Genders
NCT07303101

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

Led by University Hospital, Strasbourg, France · Updated on 2025-12-24

16

Participants Needed

1

Research Sites

35 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patient aged over 18 years at the time of prosthesis revision
  • Surgery performed at Strasbourg University Hospitals between January 1, 2013, and December 31, 2021
  • Hip or knee prosthesis revision surgery
  • Possible or confirmed periprosthetic Candida infection based on EBJIS diagnostic criteria
  • At least three deep samples taken for infection diagnosis (joint fluid, preoperative sample, and/or prosthesis sonication)
Not Eligible

You will not qualify if you...

  • Patients undergoing lavage, synovectomy, and implant preservation instead of replacement
  • Patients not receiving systemic antifungal treatment after prosthesis replacement
  • Patients with another confirmed Candida infection or infective endocarditis
  • Patients who were prescribed suppressive therapy before surgery

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Service de Chirurgie Orthopédique Septique - CHU de Strasbourg - France

Strasbourg, France, 67091

Actively Recruiting

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Research Team

S

Stéphane Klein, MD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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