Amoxicillin Clavulanic 500/125mg or placebo: Prophylactic antibiotic treatment
Study 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
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.
Primary outcome measure(s)
Number of patients with Blood stream infection (BSI) — ≤ 6 months after randomization Hospitalization for BSI
Number of patients with Severe blood culture negative infection — ≤ 6 months after randomization Hospitalization ≥ 3 days, or dies within 3 days, due to infection defined as: C-reactive protein (CRP) ≥ 75 and negative blood cultures, treated with iv antibiotics
Trial sites (7)
Facility
City
Region
Status
Rigshospitalet
Copenhagen
Capital Region
Not Yet Recruiting
Herlev-Gentofte Hospital
Copenhagen
Capital Region
Recruiting
North Zealand Hospital Hillerød
Hillerød
Capital Region
Not Yet Recruiting
Aarhus University Hospital
Aarhus
Middle Region
Not Yet Recruiting
Aalborg University Hospital
Aalborg
North Region
Recruiting
ZUH Roskilde
Roskilde
Region Sjælland
Recruiting
Odense University Hospital
Odense
Region South
Recruiting
More Zealand University Hospital trials in Denmark
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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