Bone and Join Infection (BJI)ESPRI-IOACNCT04583241
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
An observational study of Bone and Join Infection (BJI) and Periprosthetic Joint Infection (PJI), run by Hospices Civils de Lyon at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 30 to 75 years
- Conditions the study is for
- Bone and Join Infection (BJI), Periprosthetic Joint Infection (PJI)
- What is being tested?
- Constitution of serum bank at D0, Constitution of serum bank during follow-up and ELISA assays of serum markers of bone remodeling at D0
- How many people
- 28 participants
- Where
- 1 siteFrance
- Study dates
- 27 Nov 2020to 26 Jan 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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
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- 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
Who cannot join
- Polymicrobial infection
- Known inflammatory disease
- Hyperthyroidism
- Cushing's disease
- Osteomalacia
- Renal osteodystrophy
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
- Being tested
- Constitution of serum bank at D0, Constitution of serum bank during follow-up, ELISA assays of serum markers of bone remodeling at D0, ELISA assays of serum markers of bone remodeling during follow-up, Analysis of bacterial gene expression at D0
- Keywords
- BJI, Staphylococcus aureus, biomarkers
- Medical subject headings
- Staphylococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Constitution of serum bank at D0Other
Blood samples at Day 0 (day of surgery)
Constitution of serum bank during follow-upOther
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 D0Other
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-upOther
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 D0Other
Assessement of bacterial gene expression on surgery residual tissue (bone tissue, joint fluid, fragment of prostheses) collected at Day 0 (day of the surgery)
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Constitution of serum bank at D0; Other: Constitution of serum bank during follow-up; Other: ELISA assays of serum markers of bone remodeling at D0; Other: ELISA assays of serum markers of bone remodeling during follow-up; Other: Analysis of bacterial gene expression at D0 | |
| 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 Receives: Other: Constitution of serum bank at D0; Other: ELISA assays of serum markers of bone remodeling at D0; Other: Analysis of bacterial gene expression at D0 | |
| 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 Receives: Other: Constitution of serum bank at D0; Other: ELISA assays of serum markers of bone remodeling at D0; Other: Analysis of bacterial gene expression at D0 | |
| Control Group with cruciate ligament surgery | Patients having cruciate ligament surgery Patient of this group are follow-up until surgery. Receives: Other: Constitution of serum bank at D0; Other: ELISA assays of serum markers of bone remodeling at D0; Other: Analysis of bacterial gene expression at D0 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At the time of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2020
- Study start27 Nov 2020
- Primary completion26 Jan 2022
- Study completion26 Jan 2022
Why it stopped: difficulties in including patients with Staphylococcus aureus infection
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone and Join Infection (BJI)Studies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tristan FERRY, Pr, Principal investigator, Service Maladies Infectieuses et Tropicales, CRIOAC Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04583241
- Sponsor's protocol ID
- 69HCL20_0235
- Acronym
- ESPRI-IOAC
- Status last verified
- Jun 2022
- First submitted
- 5 Oct 2020
- Last updated
- 23 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04583241
- Acronym / sponsor ID
- ESPRI-IOAC / 69HCL20_0235
- Keywords
- BJI, Staphylococcus aureus, biomarkers
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: difficulties in including patients with Staphylococcus aureus infection
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 27 Nov 2020 (actual)
- Primary completion
- 26 Jan 2022 (actual)
- Study completion
- 26 Jan 2022 (actual)
- First posted
- 12 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| BJI group | – | Other: Constitution of serum bank at D0, Other: Constitution of serum bank during follow-up, Other: ELISA assays of serum markers of bone remodeling at D0, Other: ELISA assays of serum markers of bone remodeling during follow-up, Other: Analysis of bacterial gene expression at D0Patients 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 | – | Other: Constitution of serum bank at D0, Other: ELISA assays of serum markers of bone remodeling at D0, Other: Analysis of bacterial gene expression at D0Patients 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 | – | Other: Constitution of serum bank at D0, Other: ELISA assays of serum markers of bone remodeling at D0, Other: Analysis of bacterial gene expression at D0Patients 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 | – | Other: Constitution of serum bank at D0, Other: ELISA assays of serum markers of bone remodeling at D0, Other: Analysis of bacterial gene expression at D0Patients having cruciate ligament surgery Patient of this group are follow-up until surgery. |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (19 listed)
- Polymicrobial infection
- Known inflammatory disease
- Hyperthyroidism
- Cushing's disease
- Osteomalacia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Constitution of serum bank at D0Blood samples at Day 0 (day of surgery) | Other | BJI group, Control Group With material, Control Group with cruciate ligament surgery, Group osteomyelitis |
| Constitution of serum bank during follow-upBlood 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. | Other | BJI group |
| ELISA assays of serum markers of bone remodeling at D0Assessment 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) | Other | BJI group, Control Group With material, Control Group with cruciate ligament surgery, Group osteomyelitis |
| ELISA assays of serum markers of bone remodeling during follow-upAssessment 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 | Other | BJI group |
| Analysis of bacterial gene expression at D0Assessement of bacterial gene expression on surgery residual tissue (bone tissue, joint fluid, fragment of prostheses) collected at Day 0 (day of the surgery) | Other | BJI group, Control Group With material, Control Group with cruciate ligament surgery, Group osteomyelitis |
Primary outcome
Dosages of serum osteocalcin
Time frame: At the time of surgery
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.
Dosages of serum procollagen propeptide type 1
Time frame: At the time of surgery
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.
Dosages of serum cross-linked telopeptide of type 1 collagen
Time frame: At the time of surgery
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.
Dosages of serum periostin
Time frame: At the time of surgery
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.
Results and safety
The study was stopped early (reason given: difficulties in including patients with Staphylococcus aureus infection). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2022.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tristan FERRY, Pr principal investigator
Service Maladies Infectieuses et Tropicales, CRIOAC Lyon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bone and Join Infection (BJI) and Periprosthetic Joint Infection (PJI), run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 23 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: difficulties in including patients with Staphylococcus aureus infection). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dosages of serum osteocalcin (time frame: At the time of surgery). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2022.