Molecular Microbiology in Osteo-arthritis Infection (NCT01193803) | Clinical Trial Compass
CompletedNot Applicable
Molecular Microbiology in Osteo-arthritis Infection
France229 participantsStarted 2008-10
Plain-language summary
Osteoarticular infections are painful and disabling diseases that require antimicrobial treatment adapted to the microorganisms implicated. Microbiological cultures are currently regarded as the reference for identification of pathogenic bacteria. However, the sensitivity of these cultures is very variable and depends both on the context in which clinical samples are taken, and on the pathogen involved. The rate of detection varies according to infection type: from 50 to 70% for infectious spondylodiscitis, 65 to 95% for prosthetic joint infections, 50% for gonococcal arthritis and 90% for non-gonococcal arthritis. The aim of the study is to evaluate the diagnostic performances of microbiological cultures and molecular methods in case of osteoarticular infections. The gold standard will be established by an expert group of osteoarticular infection (composed by a bacteriologist, a radiologist, a surgeon, an anatomy-pathologist and a rheumatologist), which established the final diagnosis of infected or not infected patients.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 edgi…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Prosthetic Joint Infections, Vertebral Osteomyelitis and Septic arthritis: Frequency of detection with classical bacteriological methods and molecular methods