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)

Rigshospitalet

Copenhagen, Capital Region, Denmark

Herlev-Gentofte Hospital

Copenhagen, Capital Region, Denmark

North Zealand Hospital Hillerød

Hillerød, Capital Region, Denmark

Aarhus University Hospital

Aarhus, Middle Region, Denmark

Aalborg University Hospital

Aalborg, North Region, Denmark

ZUH Roskilde

Roskilde, Region Sjælland, Denmark

Odense University Hospital

Odense, Region South, Denmark

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NCT05248620


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