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

Periprosthetic Joint Infection (PJI) Clinical Trial

— ESPRI-IOAC  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04583241
• Other study ID #: 69HCL20_0235
• Status: Terminated
• Start date: November 27, 2020
• Est. completion date: January 26, 2022

Study information

• Verified date: June 2022
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 28
• Est. completion date: January 26, 2022
• Est. primary completion date: January 26, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 75 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

• Corticosteroid therapy in progress at the time of inclusion

• Active infection with HIV (human immunodeficiency virus), HBV (hepatitis B virus), HCV hepatitis C virus) documented in the patient file

• Antibiotic treatment in the 15 days preceding inclusion

• People placed under judicial protection

Related Conditions & MeSH terms

• Arthritis, Infectious
• Bone and Join Infection (BJI)
• Communicable Diseases
• Infections
• Periprosthetic Joint Infection (PJI)

Intervention

Other:
• Constitution of serum bank at D0
Blood samples at Day 0 (day of surgery)
• Constitution of serum bank during follow-up
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.
• ELISA assays of serum markers of bone remodeling at D0
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)
• ELISA assays of serum markers of bone remodeling during follow-up
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
• Analysis of bacterial gene expression at D0
Assessement of bacterial gene expression on surgery residual tissue (bone tissue, joint fluid, fragment of prostheses) collected at Day 0 (day of the surgery)

Locations

Country	Name	City	State
France	Hôpital Croix Rousse	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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