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RecruitingNCT07303101CPCIUpdated Dec 24, 2025

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

An observational study in Candida Infection, sponsored by University Hospital, Strasbourg, France. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-24.

Sponsored by University Hospital, Strasbourg, France · Observational

From the registry’s dates

  • Primary completion was expected by Feb 2026, 9 months ago, but the record still lists the study as recruiting.
  • Started May 2025; still recruiting 1 year 5 months later.
Study type
Observational
Model
Case-only
Time perspective
Retrospective
Enrollment
16
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Candida Infection

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Keywords

  • Candida infection
  • Prosthesis replacement
03

In context

Candidiasis

132 studies on the registry are indexed under Candidiasis; 9 are open to participants now.

This study's planned enrollment of 16 is below the median of 162 across 39 observational studies indexed under Candidiasis.

Browse Candidiasis studies →

Lead sponsor

University Hospital, Strasbourg, France is the lead sponsor of 999 studies on the registry; 358 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Adult subject having hip or knee prosthesis revision

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Observational model
Case-only
Time perspective
Retrospective
Enrollment
16 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Candida spp. infection eradication rate

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

07

Study locations

1 of 1 sites recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 24, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07303101
Responsible party
Sponsor
First posted
Dec 24, 2025
Start date
May 28, 2025
Primary completion
Feb 2026 (estimated)
Completion
Feb 2026 (estimated)
Last update
Dec 24, 2025

Study contacts

Stéphane Klein, MD
Contact
stephane.klein@chru-strasbourg.fr
33 3 68 76 52 32

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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