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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT02467712
Other study ID # 2014-67
Secondary ID
Status Not yet recruiting
Phase N/A
First received June 7, 2015
Last updated June 7, 2015
Start date July 2015
Est. completion date July 2016

Study information

Verified date June 2015
Source University Hospital, Strasbourg, France
Contact Jean-Yves JENNY, MD
Phone 33.3.88.55.21.45
Email jean-yves.jenny@chru-strasbourg.fr
Is FDA regulated No
Health authority France: Ministry of Health
Study type Observational

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 4
Est. completion date July 2016
Est. primary completion date July 2016
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Time Perspective: Retrospective


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Strasbourg, France

Outcome

Type Measure Description Time frame Safety issue
Primary Fungal infection for the duration of hospital stay, up to 1 year No