- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02467712
Fungal Infection on a Joint Prosthesis
June 7, 2015 updated by: University Hospital, Strasbourg, France
Change in Joint Prosthesis in One Step Due to Fungal Infection
It is generally accepted that the fungal infection on a joint prosthesis is to be treated in two surgical time: implant removal and prosthetic reconstruction.
The service took the option for over 10 years to treat bacterial infections in joint replacement by a change in time.
In four recent cases the diagnosis initially suspected of bacterial infection has been restated on intraoperative bacteriological examinations fungal infection.
It is therefore a potentially harmful side effect of the chosen treatment option, but 4 patients in question were all cured of their fungal infection after a postoperative antifungal therapy.
The objective of this study is to report these cases for discussion on the therapeutic choices in fungal infections on joint replacement.
Study Overview
Status
Unknown
Conditions
Study Type
Observational
Enrollment (Anticipated)
4
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
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients over 18 years having surgery for the management of fungal infection after change in one step in joint replacement prothesis in the participating services in 2014.
Description
Inclusion Criteria:
- Patients over 18 years
- Patient having surgery for the management of fungal infection after change in one step in joint replacement prothesis in the participating services in 2014.
Exclusion Criteria:
- Patients under 18 years
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 |
---|---|
Fungal infection
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.
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
July 1, 2015
Primary Completion (Anticipated)
July 1, 2016
Study Completion (Anticipated)
July 1, 2016
Study Registration Dates
First Submitted
June 7, 2015
First Submitted That Met QC Criteria
June 7, 2015
First Posted (Estimate)
June 10, 2015
Study Record Updates
Last Update Posted (Estimate)
June 10, 2015
Last Update Submitted That Met QC Criteria
June 7, 2015
Last Verified
June 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2014-67
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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