NCT05248620 Prophylactic Antibiotic Treatment in Hemodialysis
| NCT ID | NCT05248620 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Zealand University Hospital |
| Condition | Hemodialysis |
| Study Type | INTERVENTIONAL |
| Enrollment | 800 participants |
| Start Date | 2022-02-14 |
| Primary Completion | 2028-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 800 participants in total. It began in 2022-02-14 with a primary completion date of 2028-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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.
Contact & Investigator
Niels E Bruun, Professor
PRINCIPAL INVESTIGATOR
Dept. cardiology, Zealand University Hospital, Roskilde, Denmark
Frequently Asked Questions
Who can join the NCT05248620 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Hemodialysis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05248620 currently recruiting?
Yes, NCT05248620 is actively recruiting participants. Contact the research team at nbru@regionsjaelland.dk for enrollment information.
Where is the NCT05248620 trial being conducted?
This trial is being conducted at Copenhagen, Denmark, Copenhagen, Denmark, Hillerød, Denmark, Aarhus, Denmark and 3 additional locations.
Who is sponsoring the NCT05248620 clinical trial?
NCT05248620 is sponsored by Zealand University Hospital. The principal investigator is Niels E Bruun, Professor at Dept. cardiology, Zealand University Hospital, Roskilde, Denmark. The trial plans to enroll 800 participants.