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Prophylactic Antibiotic Treatment in Hemodialysis

RecruitingNAAges 18 Years - anyAllZealand University Hospital
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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.
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What it tests

  • Amoxicillin Clavulanic 500/125mg or placebo
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Where

7 sites
Rigshospitalet
Copenhagen, Denmark
Herlev-Gentofte Hospital
Copenhagen, Denmark
North Zealand Hospital Hillerød
Hillerød, Denmark
Aarhus University Hospital
Aarhus, Denmark
Aalborg University Hospital
Aalborg, Denmark
ZUH Roskilde
Roskilde, Denmark
Odense University Hospital
Odense, Denmark
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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