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

December 11, 2025 updated by: University Hospital, Strasbourg, France

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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

16

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Strasbourg, France, 67091
        • Recruiting
        • Service de Chirurgie Orthopédique Septique - CHU de Strasbourg - France
        • Contact:
        • Principal Investigator:
          • Stéphane KLEIN, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adult subject having hip or knee prosthesis revision

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Candida spp. infection eradication rate
Time Frame: for the duration of hospital stay, up to 1 year
for the duration of hospital stay, up to 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Strasbourg, France

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 28, 2025

Primary Completion (Estimated)

February 1, 2026

Study Completion (Estimated)

February 1, 2026

Study Registration Dates

First Submitted

December 11, 2025

First Submitted That Met QC Criteria

December 11, 2025

First Posted (Actual)

December 24, 2025

Study Record Updates

Last Update Posted (Actual)

December 24, 2025

Last Update Submitted That Met QC Criteria

December 11, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 9477

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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