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:
2025-12-24 @ 11:04 PM
Ignite Modification Date:
2025-12-24 @ 11:04 PM
NCT ID:
NCT06093269
Eligibility Criteria:
Inclusion Criteria:
1. Subjects aged 18 or over
2. On chronic intermittent dialysis
3. With a stated indication for initiation of cefazolin either:
1. For probabilistic treatment of a clinical presentation suggestive of MSSA infection
2. for treatment of Gram-positive cocci bacteremia
4. With the possibility of taking peripheral blood samples or samples from the dialysis machine until the next dialysis session at 48 hours.
5. Included within a maximum of one week after the first cefazolin injection.
6. Affiliated with French social security
7. Having signed an informed consent form
Exclusion Criteria:
1. Pregnant or breast-feeding women
2. Dialysis lasting less than 3 hours, which most often corresponds to "acute" dialysis or the start of chronic dialysis, which fundamentally changes the elimination profile.
3. Allergy to cephalosporin and penicillin antibiotics (5-10% risk of cross-reactivity).
4. Non-anuric subjects with inhibitors of tubular creatinine secretion:
1. Curative-dose trimethoprim
2. Cimetidine
3. Ritonavir, Rilpivirine, Dolutegravir, Cobicistat
5. Subjects under guardianship, curatorship or safeguard of justice
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06093269
Study Brief:
Protocol Section:
NCT06093269