Prophylactic Antibiotic Treatment in Hemodialysis
Recruiting now · Not applicable · Has a placebo group
Conditions studied: Hemodialysis
In brief
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.
Key facts
- Study ID
- NCT05248620
- Run by
- Zealand University Hospital
- People needed
- 800
- Starts
- 2022-02-14
- Expected to finish
- 2029-05-01
- Last updated by the study team
- 2024-01-30
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.
Where it is running
- Aalborg University Hospital — Aalborg, North Region, Denmark (enrolling)
- ZUH Roskilde — Roskilde, Region Sjælland, Denmark (enrolling)
- Odense University Hospital — Odense, Region South, Denmark (enrolling)
- Herlev-Gentofte Hospital — Copenhagen, Capital Region, Denmark (enrolling)
- Aarhus University Hospital — Aarhus, Middle Region, Denmark
- North Zealand Hospital Hillerød — Hillerød, Capital Region, Denmark
- Rigshospitalet — Copenhagen, Capital Region, Denmark
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.