Preventing infections in hemodialysis patients with antibiotics

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Herlev-Gentofte Hospital
  Copenhagen, Capital Region, Denmark Recruiting
• Aalborg University Hospital
  Aalborg, North Region, Denmark Recruiting
• ZUH Roskilde
  Roskilde, Region Sjælland, Denmark Recruiting
• Odense University Hospital
  Odense, Region South, Denmark Recruiting
• Rigshospitalet
  Copenhagen, Capital Region, Denmark Not yet recruiting
• North Zealand Hospital Hillerød
  Hillerød, Capital Region, Denmark Not yet recruiting

Study contacts

• Principal investigator: Niels E Bruun, Professor — Dept. cardiology, Zealand University Hospital, Roskilde, Denmark
• Study coordinator: Niels E Bruun, Professor
• Email: nbru@regionsjaelland.dk
• Phone: +4525159309

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.