Ignite Creation Date:
2024-05-06 @ 3:18 PM
Last Modification Date:
2024-10-26 @ 1:46 PM
Study NCT ID:
NCT04583241
Status:
TERMINATED
Last Update Posted:
2022-06-23
First Post:
2020-10-05
Brief Title:
Prospective Study of Patients Treated for Bone and Joint Infection BJI Due to Staphylococcus Aureus Aiming at Identifying Biomarkers of Diagnosis Interest in Chronic BJI
Sponsor:
Hospices Civils de Lyon
Organization:
Hospices Civils de Lyon
Study Overview
Official Title:
Prospective Study of Patients Treated for Bone and Joint Infection BJI Due to Staphylococcus Aureus Aiming at Identifying Biomarkers of Diagnosis Interest in Chronic BJI
Status:
TERMINATED
Status Verified Date:
2022-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
difficulties in including patients with Staphylococcus aureus infection
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ESPRI-IOAC
Brief Summary:
There are more than one million 40000 cases per year in France of osteoarticular infections OAI yearly in the world The number of these infections is constantly increasing due to an increase in life expectancy associated with an increase in prosthesis fitting as well as an increase in comorbid factors These are severe pathologies associated with mortality 5 and significant morbidity 40 responsible for functional sequelae with an individual cost prolonged hospitalization altered quality of life disability and societal sick leave partial disability or total temporary or permanent extremely high In addition reinfection rates within two years of treatment are high
The BJIs are a group of clinical entities that have in common the invasion and progressive destruction of bone and cartilage tissue by bacterial-like microorganisms
Staphylococcus spp is the main pathogen 50 in BJI and is associated with particularly difficult to treat infections with a high rate of chronicity and relapses especially in case of implanted material
The difficulty in managing these infections is partly linked on the one hand to the fact that the pathogens are in persistent metabolic forms and in intracellular reservoirs which make them insensitive to conventional antibiotics and on the other hand the absence of reliable markers of the infection and above all of its clinical resolution which complicates clinical trials
ESPRI-IOAC is a consortium of 4 partners private-public from Lyon area and which aims at
studying the translational value of BJI preclinical models
identifying biomarkers of infection in preclinical models and at assessing them in a prospective study
The current study is part of the global ESPRI-IOAC consortium and represent the clinical application
It is a prospective study of patients treated for BJI in the infectious disease department of the Hospices Civils de Lyon La Croix-Rousse for osteo-articular infections due to Staphylococcus aureus or for simple mechanical revision or for cruciate ligament surgery the objective of which is to highlight biomarkers of interest in the diagnosis of chronic BJI and or predictive of the therapeutic response
The translational value of the experimental models used in the BJI will also be studied
The BJIs are a group of clinical entities that have in common the invasion and progressive destruction of bone and cartilage tissue by bacterial-like microorganisms
Staphylococcus spp is the main pathogen 50 in BJI and is associated with particularly difficult to treat infections with a high rate of chronicity and relapses especially in case of implanted material
The difficulty in managing these infections is partly linked on the one hand to the fact that the pathogens are in persistent metabolic forms and in intracellular reservoirs which make them insensitive to conventional antibiotics and on the other hand the absence of reliable markers of the infection and above all of its clinical resolution which complicates clinical trials
ESPRI-IOAC is a consortium of 4 partners private-public from Lyon area and which aims at
studying the translational value of BJI preclinical models
identifying biomarkers of infection in preclinical models and at assessing them in a prospective study
The current study is part of the global ESPRI-IOAC consortium and represent the clinical application
It is a prospective study of patients treated for BJI in the infectious disease department of the Hospices Civils de Lyon La Croix-Rousse for osteo-articular infections due to Staphylococcus aureus or for simple mechanical revision or for cruciate ligament surgery the objective of which is to highlight biomarkers of interest in the diagnosis of chronic BJI and or predictive of the therapeutic response
The translational value of the experimental models used in the BJI will also be studied
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None