Study Stopped
difficulties in including patients with Staphylococcus aureus infection
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
ESPRI-IOAC
1 other identifier
observational
28
1 country
1
Brief Summary
There are more than one million (\> 40,000 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Nov 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 5, 2020
CompletedFirst Posted
Study publicly available on registry
October 12, 2020
CompletedStudy Start
First participant enrolled
November 27, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 26, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
January 26, 2022
CompletedJune 23, 2022
June 1, 2022
1.2 years
October 5, 2020
June 17, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Dosages of serum osteocalcin
Comparison of dosages by ELISA test of serum osteocalcin between the patients with OAI and the "control" patients without OAI at the time of inclusion in order to demonstrate a marker or a combination of markers for OAI.
At the time of surgery
Dosages of serum procollagen propeptide type 1
Comparison of dosages by ELISA test of serum procollagen propeptide type 1 between the patients with OAI and the "control" patients without OAI at the time of inclusion in order to demonstrate a marker or a combination of markers for OAI.
At the time of surgery
Dosages of serum cross-linked telopeptide of type 1 collagen
Comparison of dosages by ELISA test of serum cross-linked telopeptide of type 1 collagen between the patients with OAI and the "control" patients without OAI at the time of inclusion in order to demonstrate a marker or a combination of markers for OAI.
At the time of surgery
Dosages of serum periostin
Comparison of dosages by ELISA test of serum periostin between the patients with OAI and the "control" patients without OAI at the time of inclusion in order to demonstrate a marker or a combination of markers for OAI.
At the time of surgery
Study Arms (4)
BJI group
Patients with an BJI on material (prosthesis or other implant) infected by Staphylococcus aureus\* Patients are follow-up during two years after surgery. \*Diagnosis of staphylococcus aureus monoinfection realized a posteriori after surgery on bacteriological sample
Control Group With material
Patients with mechanical problems on implanted equipment (control cohort), without infection\* Patient of this group are follow-up until surgery. \*Diagnosis of staphylococcus aureus monoinfection realized a posteriori after surgery on bacteriological sample
Group osteomyelitis
Patients with chronic osteomyelitis\* Patient of this group are follow-up until surgery. \*Diagnosis of staphylococcus aureus monoinfection realized a posteriori after surgery on bacteriological sample
Control Group with cruciate ligament surgery
Patients having cruciate ligament surgery Patient of this group are follow-up until surgery.
Interventions
Blood samples at Day 0 (day of surgery)
Blood samples are obtained at week 2, week 6 post-surgery, at the end of antibiotherapy and 6 months post-surgery, only for patients with staphylococcus aureus monoinfection who are follow-up during two years.
Assessment by ELISA assays of serum markers of bone remodelling: the osteocalcin (OC), the procollagen propeptide type 1 (PINP), the cross linked telopeptide of type 1 collagen (CTX1) and the periostin at Day 0 (day of surgery)
Assessment by ELISA assays of serum markers of bone remodelling: the osteocalcin (OC), the procollagen propeptide type 1 (PINP), the cross linked telopeptide of type 1 collagen (CTX1) and the periostin at week 2, week 6 post-surgery, at the end of antibiotherapy and 6 months post-surgery, only for patients with staphylococcus aureus monoinfection who are follow-up during two years
Assessement of bacterial gene expression on surgery residual tissue (bone tissue, joint fluid, fragment of prostheses) collected at Day 0 (day of the surgery)
Eligibility Criteria
Patients treated in the orthopedic surgery and infectious diseases departments of the Hospices Civils de Lyon, Croix-Rousse Hospital, for osteo-articular infections, due to Staphylococcus aureus, for simple mechanical revision or for cruciate ligament surgery.
You may qualify if:
- Age ≥ 30 years old
- Hospitalized in orthopedic surgery for one of these reasons:
- A suspected infection or a documented proven infection with staphylococcus aureus on prosthesis or other orthopedic implant
- A mechanical cause (absence of infection) on prosthesis or orthopedic implant
- Documented chronic osteomyelitis due to staphylococcus aureus
- Cruciate ligament surgery
- Patient not subject to any legal protection measure
- Patient who can be followed in the Infectious and Tropical Diseases Department, CRIOAC Lyon ("Centre de Référence des Infections Ostéo-Articulaires complexes" = reference centre of bone and joint infections in french), La Croix-Rousse for at least 6 months post-surgery
- Patient who gave his no-opposition
- Patient giving his consent to the creation of biological collections
You may not qualify if:
- Polymicrobial infection
- Known inflammatory disease
- Hyperthyroidism
- Cushing's disease
- Osteomalacia
- Renal osteodystrophy
- Paget's disease
- Malignant disease in progress
- Multiple myeloma
- Bone metastases
- Ehlers-Danlos syndrome
- Pregnant or lactating woman
- Renal impairment (Creatinine clearance \<60 mL / min)
- Trauma in the 6 months preceding surgery
- Fracture in the 6 months preceding surgery
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hôpital Croix Rousse
Lyon, 69004, France
Biospecimen
* Collection of serum : Blood samples are obtained at different times : Day 0 (day of surgery), and for patients with staphylococcus aureus monoinfection who are follow-up during two years, at week 2, week 6 post-surgery, at the end of antibiotherapy and 6 months post-surgery) * Tissue bank : Recovery of residual samples of bone tissue, joint fluid, fragment of prostheses the day of surgery
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Tristan FERRY, Pr
Service Maladies Infectieuses et Tropicales, CRIOAC Lyon
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 5, 2020
First Posted
October 12, 2020
Study Start
November 27, 2020
Primary Completion
January 26, 2022
Study Completion
January 26, 2022
Last Updated
June 23, 2022
Record last verified: 2022-06