An interventional study of Amoxicillin Clavulanic 500/125mg or placebo in Hemodialysis, sponsored by Zealand University Hospital. Recruiting at 7 sites in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-10.
Sponsored by Zealand University Hospital · Not applicable, Interventional, and Prevention
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.
Zealand University Hospital is the lead sponsor of 236 studies on the registry; 50 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Patients may be rescreened later i.e. within a time period of one month from start of HD, if exclusion criteria are reversible.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Amoxicillin/clavulanic acid 500/125mg, tablets, will be administered before each hemodialysis for 6 months
Drug: Amoxicillin Clavulanic 500/125mg or placebo
Placebo tablets, similar to the active drug, will be administered before each hemodialysis for 6 months
Drug: Amoxicillin Clavulanic 500/125mg or placebo
Prophylactic antibiotic treatment
Also known as: Aurobindo
Number of patients with Blood stream infection (BSI)
Hospitalization for BSI
Time frame: ≤ 6 months after randomization
Number of patients with Severe blood culture negative infection
Hospitalization ≥ 3 days, or dies within 3 days, due to infection defined as: C-reactive protein (CRP) ≥ 75 and negative blood cultures, treated with iv antibiotics
Time frame: ≤ 6 months after randomization
Number of patients with BSI or severe blood culture negative infection
Each of the components in the primary endpoint
Time frame: ≤ 6 months after randomization
Mortality
All-cause mortality
Time frame: ≤ 6 months after randomization
Number of patients with Sepsis
Hospitalization due to sepsis or septic shock
Time frame: ≤ 6 months after randomization
Number of patients with Deep tissue infection
Infective endocarditis, osteomyelitis, and spondylodiscitis
Time frame: ≤ 6 months after randomization
Number of patients with Autoinfection
Frequency of BSI autoinfection
Time frame: ≤ 6 months after randomization
Number of patients with Clostridium difficile infection
Clostridium difficile infection - numbers and days of admission
Time frame: ≤ 6 months after randomization
Mortality due to infection - number of patients
Mortality due to infection
Time frame: ≤ 6 months after randomization
Number of CVC removals
CVC removal due to CVC infection
Time frame: ≤ 6 months after randomization
Use of Antibiotics in Difined Daily Doses
Total use of antibiotics in Defined Daily Doses
Time frame: ≤ 6 months after randomization
Healt-care economics
Health-care related economic consequences due to hospitalization and treatment of the disease
Time frame: ≤ 6 months after randomization
Number of patients with Extended Spectrum Beta-Lactamase (ESBL) infection
ESBL infections - number of patients and days of admission
Time frame: ≤ 6 months after randomization
Number of patients with Methicillin-resistant Staphylococcus aureus (MRSA) infection
MRSA infections - number of patients and days of admission
Time frame: ≤ 6 months after randomization
Number of patients with Carbapenemase-Producing Organisms (CPO) infection
CPO infections - number og patients and days of admission
Time frame: ≤ 6 months after randomization
Number of patients with Vancomycin-resistant enterococci (VRE) infection
VRE infections - number of patients and days of admission
Time frame: ≤ 6 months after randomization
Number of patients with Cardiovascular events
Hospitalization with acute myocardial infarction, worsening heart failure or stroke
Time frame: ≤ 6 months after randomization
Plan to share: No — No plan
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