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 @ 4:10 AM
Ignite Modification Date:
2025-12-25 @ 4:10 AM
NCT ID:
NCT05248620
Eligibility Criteria:
Inclusion Criteria:
* End Stage Kidney Disease (ESKD) patients who receive an uncuffed or cuffed CVC for expected chronic HD, regardless of previous ESKD treatment modality (PD or KTX) and hemodialysis access (AV-fistula or AV-graft))
* ≥18 years
* Ability to understand the study background, risk and benefit of treatment and to give written informed consent
Exclusion Criteria:
* Unable to give informed consent
* Known intolerance to beta-lactam antibiotics and clindamycin
* Active infection treated with antibiotics
* Breastfeeding
* Pregnancy. In women of childbearing age, an approved birth control must be ensured at least 1 month before and during all the 6 months of antibiotic/placebo treatment.
Patients may be rescreened later i.e. within a time period of one month from start of HD, if exclusion criteria are reversible.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05248620
Study Brief:
Protocol Section:
NCT05248620