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NCT Number: NCT07303101

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

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Service de Chirurgie Orthopédique Septique - CHU de Strasbourg - France

Strasbourg, 67091, France

Location status: Recruiting

Location contact

Sté Klein, MD

CONTACT

[email protected]

33 3 68 76 52 32

Stéphane Klein, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Candida spp. infection eradication rate

    Time frame: for the duration of hospital stay, up to 1 year

Study contacts

Contact information is provided by the study sponsor or research team.

Stéphane Klein, MD

CONTACT

[email protected]

33 3 68 76 52 32

Sponsors and collaborators

Lead sponsor

University Hospital, Strasbourg, France

Other

Registry information

Acronym: CPCI

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 24, 2025
Registry last updated
Dec 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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