- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04712123
Recurrent S. Aureus Infections in Osteoarticular Infections (RELAPSTAPH)
January 19, 2022 updated by: Hospices Civils de Lyon
Staphylococcus aureus osteoarticular infections, in particular those associated with the presence of implant, relapse in 20% of cases. Currently, the reasons for these relapses are poorly understood, whether on the microbiological or clinical side.
The aim of this study is to improve knowledge on persistence of mechanisms of S. aureus
Study Overview
Status
Recruiting
Intervention / Treatment
Study Type
Observational
Enrollment (Anticipated)
40
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
- Recruiting
- 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
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
patients having had an osteoarticular infection with or without material due to S. aureus and treated at CRIOAc Lyon, presenting a recurrence of S. aureus infection
Description
Inclusion Criteria:
- patients having had an osteoarticular infection with or without material due to S. aureus presenting a recurrence of S. aureus infection
Exclusion Criteria:
-
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
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
relapse due to S. aureus
patients having had an initial infection due to S. aureus and who present a relapse with persistence of S. aureus
|
to find out if it is the same S. aureus in both infections
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
rate of patients having had an osteoarticular infection due to S. aureus
Time Frame: between 2015 and 2020
|
proportion of patients having had an osteoarticular infection due to S. aureus
|
between 2015 and 2020
|
Description of patients having had an osteoarticular infection due to S. aureus
Time Frame: between 2015 and 2020
|
type of patients: age, BMI, comorbidities...
|
between 2015 and 2020
|
Description of Bone and Joint Iinfection/Prosthesis Joint Infection
Time Frame: between 2015 and 2020
|
implant or prosthesis or not, acute/ chronic, bacteriology
|
between 2015 and 2020
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
rate of patients having had a relapse due to persistence of S. aureus
Time Frame: between 2015 and 2020
|
proportion of patients having had an osteoarticular infection due persistence of S. aureus
|
between 2015 and 2020
|
rate of S. aureus strain identical between the initial episode and the relapse
Time Frame: between 2015 and 2020
|
proportion of relapse due to the same strain of S. aureus than in the initial episode
|
between 2015 and 2020
|
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)
August 1, 2021
Primary Completion (Anticipated)
December 1, 2022
Study Completion (Anticipated)
January 1, 2023
Study Registration Dates
First Submitted
January 13, 2021
First Submitted That Met QC Criteria
January 13, 2021
First Posted (Actual)
January 15, 2021
Study Record Updates
Last Update Posted (Actual)
January 20, 2022
Last Update Submitted That Met QC Criteria
January 19, 2022
Last Verified
January 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 281
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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