- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04409392
Staphylococcus Lugdunensis Prosthetic Joint Infection
June 15, 2021 updated by: Hospices Civils de Lyon
Staphylococcus Lugdunensis Prosthetic Joint Infection: a Retrospective Cohort Study
Staphylococcus lugdunensis is a coagulase-negative staphylococcus belonging to the human commensal cutaneous flora, and has been little studied in the field of prosthetic joint infections.
However, it shares many virulence traits with Staphylococcus aureus, including many adhesins and its ability to form biofilm, and the few series of cases reports a significant failure rate.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
84
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Lyon, France, 69004
- Hospices Civils de Lyon
-
-
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 having had IPA due to Staphylococcus lugdunensis
Description
Inclusion Criteria:
- infection of joint prosthesis (whatever its type) with Staphylococcus lugdunensis defined by the positivity of at least 2 gold-standard samples (joint puncture, intraoperative samples) with S. lugdunensis; OR
- a single positive gold-standard sample or positive blood cultures AND formal clinical, radiological, biological and / or pathological arguments in favor of an infection of joint prosthesis AND absence of other pathogenic agent
Exclusion Criteria:
- none
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
- Observational Models: Cohort
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Prothestic joint infection due to Staphylococcus lugdunensis
Patients having had a prosthetic joint infection with Staphylococcus lugdunensis
|
description of prosthetic joint infection with Staphylococcus lugdunensis
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rate of PJI infection with Staphylococcus lugdunensis
Time Frame: between 2010 and 2020
|
proportion of patients having PJI infection with Staphylococcus lugdunensis, alone or with other bacteria
|
between 2010 and 2020
|
Description of PJI infection with Staphylococcus lugdunensis : type
Time Frame: Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption
|
type of PJI : knee or hip prosthesis
|
Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption
|
Description of PJI infection with Staphylococcus lugdunensis : evolution
Time Frame: Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption
|
evolution of PJI :evolution between prosthesis placement and the onset of symptoms, gateway to infection
|
Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption
|
Description of patients with PJI infection due to Staphylococcus lugdunensis
Time Frame: Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption
|
type of patients: age, CMI
|
Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption
|
Description of patients with PJI infection due to Staphylococcus lugdunensis : follow up
Time Frame: Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption
|
duration of the follow up of patients
|
Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption
|
Description of patients with PJI infection due to Staphylococcus lugdunensis : medical treatment
Time Frame: Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption
|
description and duration of antibiotics
|
Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption
|
Description of patients with PJI infection due to Staphylococcus lugdunensis : surgical treatment
Time Frame: Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption
|
description of surgery performed : DAIR, one-step exchange, two-step exchange
|
Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption
|
rate of treatment failure
Time Frame: Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption
|
Treatment failure is defined by local clinical and/or microbiological relapse; and/or need for additional surgery; death of septic origin
|
Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
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 (Actual)
February 1, 2021
Primary Completion (Actual)
April 1, 2021
Study Completion (Actual)
April 1, 2021
Study Registration Dates
First Submitted
May 27, 2020
First Submitted That Met QC Criteria
May 27, 2020
First Posted (Actual)
June 1, 2020
Study Record Updates
Last Update Posted (Actual)
June 16, 2021
Last Update Submitted That Met QC Criteria
June 15, 2021
Last Verified
November 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20-202
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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