Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:12 AM
Ignite Modification Date:
2025-12-25 @ 2:12 AM
NCT ID:
NCT03246360
Eligibility Criteria:
Inclusion Criteria:
* Staphylococcus aureus sensitive to methicillin and to be treated with cloxacillin by injectable antibiotic monotherapy For patients with Osteo-articular infection on material
* Presence of a fistula in contact with the prosthesis or implant.
* Pus in the joint or in contact with the prosthesis or implant
* Presence of at least 1 positive sample (1 sampling by articular puncture or 1 peroperative sampling or by blood culture)
* A histological analysis of the peri-prosthetic osteo-articular tissue which is the object of acute inflammation is a strong argument in favor of an Osteo-articular infection on material
For spondylodiscitis
* Culture of a disco-vertebral biopsy puncture to isolate a methicillin sensitive S. aureus
* Positive haemocultures for S. aureus sensitive to methicillin with imaging examination (CT or MRI of the spine) showing images of spondylodiscitis
For primitive arthritis :
* Culture of a positive methicillin-sensitive S. aureus articular fluid puncture
* Cultivation of a methicillin-sensitive S. aureus-positive surgical joint lavage fluid
For osteitis the diagnosis is based on the following criterion:
\*Culture of surgical specimens from a focal zone of methicillin-sensitive S. aureus-positive osteitis
Exclusion Criteria:
* Allergy to betalactamines
* Taking penicillin M within 36 hours before inclusion Renal function impaired with a glomerular filtration rate measured by MDRD formula of less than 30 ml / min
* Patient with renal function expected to change within 6 days of inclusion
* Hepatocellular insufficiency, whatever the degree
-\*Methotrexate intake
* Polytransfused (more than 2 CGR) in the previous week
* Patients requiring resuscitation
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03246360
Study Brief:
Protocol Section:
NCT03246360