Preventing infections in hemodialysis patients with antibiotics

Prophylactic Antibiotic Treatment in End Stage Kidney Disease and Central Venous Catheter as Hemodialysis Vascular Access

This study is testing if giving antibiotics to people starting hemodialysis can help prevent serious infections during their treatment.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 800 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Zealand University Hospital (Academic / other)
• Locations: 7 sites (Copenhagen, Capital Region and 6 other locations)
• Trial ID: NCT05248620 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness of prophylactic antibiotic treatment in preventing blood stream infections and severe culture negative infections in patients starting hemodialysis with a central venous catheter. Eligible participants will be randomly assigned to receive either amoxicillin/clavulanic acid or a placebo before each hemodialysis session for a duration of six months. The study aims to establish a sufficient concentration of antibiotics during dialysis sessions to reduce infection rates. Participants will be monitored for side effects and followed up for one year after treatment.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with end-stage kidney disease requiring hemodialysis via a central venous catheter.

Not a fit: Patients who are intolerant to beta-lactam antibiotics or clindamycin, or those with active infections being treated with antibiotics will not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly reduce the incidence of infections in hemodialysis patients, improving their overall health outcomes.

How similar studies have performed: Previous studies have shown promising results with prophylactic antibiotics in similar patient populations, suggesting potential for success in this approach.

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.

Where this trial is running

Copenhagen, Capital Region and 6 other locations

• Rigshospitalet — Copenhagen, Capital Region, Denmark (Not_yet_recruiting)
• Herlev-Gentofte Hospital — Copenhagen, Capital Region, Denmark (Recruiting)
• North Zealand Hospital Hillerød — Hillerød, Capital Region, Denmark (Not_yet_recruiting)
• Aarhus University Hospital — Aarhus, Middle Region, Denmark (Not_yet_recruiting)
• Aalborg University Hospital — Aalborg, North Region, Denmark (Recruiting)
• ZUH Roskilde — Roskilde, Region Sjælland, Denmark (Recruiting)
• Odense University Hospital — Odense, Region South, Denmark (Recruiting)

Study contacts

• Principal investigator: Niels E Bruun, Professor — Dept. cardiology, Zealand University Hospital, Roskilde, Denmark
• Study coordinator: Niels E Bruun, Professor

Conditions Hemodialysis; Blood stream infections; Severe culture negative infections; Central venous catheter; Prophylactic antibiotics