- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01193803
Molecular Microbiology in Osteo-arthritis Infection (MOLOS)
Interest of Molecular Biology for Diagnostic of Osteo-arthritis Infections. EE Observational Prospective Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Paris, France, 75010
- Hopital Lariboisiere
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patient are more than 18 years old
- Patient who do not declined to have his medical records reviewed for research
Spondylodiscitis (S) group:
- Patients suspected of Discitis and/or Vertebral Osteomyelitis is defined by the need of spinal biopsy in infectious context. Spinal biopsies will be justified by one or more clinical or imaging findings:
- Clinical presentation
- Spinal pain unrelieved by rest
- Localized tenderness, Neurological deficits or limited range of motion
Fever > 38°C
- Imaging findings (plain radiographs, MRI or CT):
- Erosions of end plates on adjacent vertebral bodies
- Decreased height of the intervertebral disk
- Presence of a nonvascularized zone suggesting presence of pus or necroses in intervertebral, epidural space or in paraspinal soft-tissues
Prosthetic Joint Infection (PJI) Group
Patients suspected of Prosthetic Joint Infection were defined by the need of surgical revision for diagnostic or therapeutic aiming in infectious context. This revision will be justified by one or more clinical, biological or imaging findings:
Clinical presentation
- Persistent joint pain
- Fever > 38°C
- Erythematous, swollen, fluctuant, and/or tender surgical wound
- Wound dehiscence
- Limited range of joint motion
Biological findings
- CRP > 10 mg/l
- Synovial leukocytes count > 1500/mm3 and polymorphonuclear leukocytes > 65%
Imaging findings
- Prosthesis loosening: Periprosthetic osteolysis, progressive peri-prosthetic edging
- Scintigraphy by means of a technetium (Tc99m) scan, gallium citrate (Ga67) scan, or indium (In111)-labeled leukocyte showing fixation around the prosthesis.
Septic arthritis (SA) Group
- Patients suspected of Septic arthritis without prosthesis were defined by the need of synovial punction and/or biopsy justified by one or more clinical, biological or imaging findings:
Clinical presentation
- Acute joint pain and/or swelling
- Adenopathy near inflammatory joint
- Fever > 38°CBiological findings
- WBC > 10 000/ mm3
- CRP > 10 mg/l
- Synovial leukocytes count > 2000/mm3 or polymorphonuclear leukocytes > 90%
Imaging findings:
- Capsular and surrounding soft-tissues swelling
- Synovial notch and/or demineralization
- Periarticular Abscess
Exclusion criteria:
- Patients already include.
- Patient without health insurance
- Antibiotic treatment before sampling does not constitute an exclusion criterion
Exclusion criteria for control groups:
Patient with one or more criteria:
- Suspicion of concomitant infection defined by a fever >38°C and CRP > 10mg/l
- Arthrosis treated by infiltration in the 6 months which preceding inclusion
- Rapidly progressive arthrosis Prosthesis loosening or bone necrosis presumed to be aseptic
- Patients with prior spinal instrumentation or surgery
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Spondylodiscitis control group
Patients needing vertebral biopsy looking for tumoral etiology
|
Biological/Vaccine: Microbiological cultures and Molecular Biology Bacteriological procedures: All solid specimens will be crushed using a mechanic apparatus. Direct examination and cultures will be performed according to the guidelines applied for osteoarticular infections. Cultures and subcultures will be incubated for 15 days to 3 months for Mycobacteria. Molecular procedures: DNA extraction will be based on Boom's method (QIAGEN kit and EZ1 BioRobot). Detections of bacteria will be performed by amplification and sequencing of the 16S rRNA gene. Some specific detections as the detection of Staphylococcus sp. and Mycobacterium tuberculosis will be added to this protocol. |
Prosthetic Joint Infection control group
Patients with primary prosthetic arthrosis surgery
|
Biological/Vaccine: Microbiological cultures and Molecular Biology Bacteriological procedures: All solid specimens will be crushed using a mechanic apparatus. Direct examination and cultures will be performed according to the guidelines applied for osteoarticular infections. Cultures and subcultures will be incubated for 15 days to 3 months for Mycobacteria. Molecular procedures: DNA extraction will be based on Boom's method (QIAGEN kit and EZ1 BioRobot). Detections of bacteria will be performed by amplification and sequencing of the 16S rRNA gene. Some specific detections as the detection of Staphylococcus sp. and Mycobacterium tuberculosis will be added to this protocol. |
Septic arthritis control group
Arthrosic patients needing evacuating articular punction with leucocytes infiltration less than 1000 /mm3
|
Biological/Vaccine: Microbiological cultures and Molecular Biology Bacteriological procedures: All solid specimens will be crushed using a mechanic apparatus. Direct examination and cultures will be performed according to the guidelines applied for osteoarticular infections. Cultures and subcultures will be incubated for 15 days to 3 months for Mycobacteria. Molecular procedures: DNA extraction will be based on Boom's method (QIAGEN kit and EZ1 BioRobot). Detections of bacteria will be performed by amplification and sequencing of the 16S rRNA gene. Some specific detections as the detection of Staphylococcus sp. and Mycobacterium tuberculosis will be added to this protocol. |
Spondylodiscitis case group
Patients suspected of Discitis and/or Vertebral Osteomyelitis is defined by the need of spinal biopsy in infectious context.
|
Biological/Vaccine: Microbiological cultures and Molecular Biology Bacteriological procedures: All solid specimens will be crushed using a mechanic apparatus. Direct examination and cultures will be performed according to the guidelines applied for osteoarticular infections. Cultures and subcultures will be incubated for 15 days to 3 months for Mycobacteria. Molecular procedures: DNA extraction will be based on Boom's method (QIAGEN kit and EZ1 BioRobot). Detections of bacteria will be performed by amplification and sequencing of the 16S rRNA gene. Some specific detections as the detection of Staphylococcus sp. and Mycobacterium tuberculosis will be added to this protocol. |
Prosthetic Joint Infection case group
Patients suspected of Prosthetic Joint Infection defined by the need of surgical revision for diagnostic or therapeutic aiming in infectious context.
|
Biological/Vaccine: Microbiological cultures and Molecular Biology Bacteriological procedures: All solid specimens will be crushed using a mechanic apparatus. Direct examination and cultures will be performed according to the guidelines applied for osteoarticular infections. Cultures and subcultures will be incubated for 15 days to 3 months for Mycobacteria. Molecular procedures: DNA extraction will be based on Boom's method (QIAGEN kit and EZ1 BioRobot). Detections of bacteria will be performed by amplification and sequencing of the 16S rRNA gene. Some specific detections as the detection of Staphylococcus sp. and Mycobacterium tuberculosis will be added to this protocol. |
Septic arthritis case group
Patients suspected of Septic arthritis without prosthesis were defined by the need of synovial punction and/or biopsy
|
Biological/Vaccine: Microbiological cultures and Molecular Biology Bacteriological procedures: All solid specimens will be crushed using a mechanic apparatus. Direct examination and cultures will be performed according to the guidelines applied for osteoarticular infections. Cultures and subcultures will be incubated for 15 days to 3 months for Mycobacteria. Molecular procedures: DNA extraction will be based on Boom's method (QIAGEN kit and EZ1 BioRobot). Detections of bacteria will be performed by amplification and sequencing of the 16S rRNA gene. Some specific detections as the detection of Staphylococcus sp. and Mycobacterium tuberculosis will be added to this protocol. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Prosthetic Joint Infections, Vertebral Osteomyelitis and Septic arthritis: Frequency of detection with classical bacteriological methods and molecular methods
Time Frame: Day 0
|
Day 0
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Time of returned results by one or the other of the techniques
Time Frame: up to 90 days
|
up to 90 days
|
Collaborators and Investigators
Investigators
- Principal Investigator: Beatrice BERCOT, MD,PhD, Assistance Publique - Hôpitaux de Paris
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CRC076057
- 297-08 (OTHER: CEERB)
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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