RecruitingNot ApplicableNCT05248620
Prophylactic Antibiotic Treatment in Hemodialysis
Prophylactic Antibiotic Treatment in End Stage Kidney Disease and Central Venous Catheter as Hemodialysis Vascular Access
Sponsor
Zealand University Hospital
Enrollment
800 participants
Start Date
Feb 14, 2022
Study Type
INTERVENTIONAL
Conditions
Summary
The purpose of this study is to assess the efficacy of prophylactic antibiotic treatment on blood stream infections and severe culture negative infections, in patients on newly started hemodialysis(HD), with a central venous catheter as vascular access.
Eligibility
Min Age: 18 Years
Inclusion Criteria3
- 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 Criteria5
- 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.
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Interventions
DRUGAmoxicillin Clavulanic 500/125mg or placebo
Prophylactic antibiotic treatment
Locations(7)
View Full Details on ClinicalTrials.gov
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NCT05248620
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