Prophylactic Antibiotic Treatment in Hemodialysis

Last updated: January 28, 2024
Sponsor: Zealand University Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Hemodialysis

Treatment

Amoxicillin Clavulanic 500/125mg or placebo

Clinical Study ID

NCT05248620
H-20026735
  • Ages > 18
  • All Genders

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 Criteria

Inclusion

Inclusion Criteria:

  • End Stage Kidney Disease (ESKD) patients who receive an uncuffed or cuffed CVC forexpected chronic HD, regardless of previous ESKD treatment modality (PD or KTX) andhemodialysis access (AV-fistula or AV-graft))
  • ≥18 years
  • Ability to understand the study background, risk and benefit of treatment and to givewritten informed consent

Exclusion

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 atleast 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.

Study Design

Total Participants: 800
Treatment Group(s): 1
Primary Treatment: Amoxicillin Clavulanic 500/125mg or placebo
Phase:
Study Start date:
February 14, 2022
Estimated Completion Date:
May 31, 2029

Study Description

After being informed about the study and potential risks all eligible patients, giving written informed consent will be included in the study. At week 0 patients will be randomized in a single blinded manner (participants and care providers) in a 1:1 manner to receive 500/125mg amoxicillin/clavulanic acid 30-120 minutes before each hemodialysis with a central venous catheter (CVC) as vascular access, or corresponding placebo. The timing of antibiotic administration has been established in a pilot-study in order to secure a sufficient concentration of antibiotics during the dialysis session. In case of side effects to amoxicillin/clavulanic acid, the prophylactic antibiotic will be shifted to 600mg clindamycin. Total treatment period with prophylactic antibiotics is 6 months, with a 1 year follow-up.

Connect with a study center

  • Herlev-Gentofte Hospital

    Copenhagen, Capital Region 2730
    Denmark

    Active - Recruiting

  • Rigshospitalet

    Copenhagen, Capital Region 2100
    Denmark

    Site Not Available

  • North Zealand Hospital Hillerød

    Hillerød, Capital Region 3400
    Denmark

    Site Not Available

  • Aarhus University Hospital

    Aarhus, Middle Region 8200
    Denmark

    Site Not Available

  • Aalborg University Hospital

    Aalborg, North Region 9100
    Denmark

    Active - Recruiting

  • ZUH Roskilde

    Roskilde, Region Sjaelland 4000
    Denmark

    Active - Recruiting

  • Odense University Hospital

    Odense, Region South 5000
    Denmark

    Active - Recruiting

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