Prophylactic Antibiotic Treatment in Hemodialysis (PANTHEM)

  • End date
    May 5, 2028
  • participants needed
  • sponsor
    Zealand University Hospital
Updated on 5 June 2022


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.


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.

Condition Hemodialysis
Treatment Amoxicillin Clavulanic 500/125mg or placebo
Clinical Study IdentifierNCT05248620
SponsorZealand University Hospital
Last Modified on5 June 2022


Yes No Not Sure

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
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
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