Candida InfectionCPCINCT07303101
One-stage Exchange in Candida Periprosthetic Infection a Suitable Way to go
An observational study of Candida Infection, run by University Hospital, Strasbourg, France at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Candida Infection
- How many people
- 16 participants
- Where
- 1 siteFrance
- Study dates
- 28 May 2025to Feb 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult subject having hip or knee prosthesis revision
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Service de Chirurgie Orthopédique Septique - CHU de Strasbourg - France
Strasbourg, 67091
Sté Klein, MD, 33 3 68 76 52 32, stephane.klein@chru-strasbourg.fr
Stéphane Klein, MD
About this study
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
- Medical subject headings
- Candidiasis
What is being measured
The primary outcome is the main question the study is designed to answer.
Candida spp. infection eradication rate
Measured: for the duration of hospital stay, up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2025
- Study start28 May 2025
- Primary completionFeb 2026 (estimated)
- Study completionFeb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Candida InfectionStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07303101
- Sponsor's protocol ID
- 9477
- Acronym
- CPCI
- Status last verified
- Dec 2025
- First submitted
- 11 Dec 2025
- Last updated
- 24 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- One-stage Exchange in Candida Periprosthetic Infection a Suitable Way to go
- ClinicalTrials.gov ID
- NCT07303101
- Acronym / sponsor ID
- CPCI / 9477
- Conditions
- Candida Infection
- Keywords
- Candida infection, Prosthesis replacement
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 28 May 2025 (actual)
- Primary completion
- Feb 2026 (estimated)
- Study completion
- Feb 2026 (estimated)
- First posted
- 24 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult subject having hip or knee prosthesis revision
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Candida spp. infection eradication rate
Time frame: for the duration of hospital stay, up to 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Candida Infection, run by University Hospital, Strasbourg, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stéphane Klein, MD (33 3 68 76 52 32, stephane.klein@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Candida spp. infection eradication rate (time frame: for the duration of hospital stay, up to 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2025.