Prophylactic Antibiotic Treatment in Hemodialysis
- Conditions
- Hemodialysis
- Interventions
- Registration Number
- NCT05248620
- Lead Sponsor
- Zealand University Hospital
- Brief 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.
- Detailed 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 800
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Active Amoxicillin Clavulanic 500/125mg or placebo Amoxicillin/clavulanic acid 500/125mg, tablets, will be administered before each hemodialysis for 6 months Placebo Amoxicillin Clavulanic 500/125mg or placebo Placebo tablets, similar to the active drug, will be administered before each hemodialysis for 6 months
- Primary Outcome Measures
Name Time Method Number of patients with Blood stream infection (BSI) ≤ 6 months after randomization Hospitalization for BSI
Number of patients with Severe blood culture negative infection ≤ 6 months after randomization Hospitalization ≥ 3 days due to infection defined as: C-reactive protein (CRP) ≥ 75 and negative blood cultures, treated with iv antibiotics
- Secondary Outcome Measures
Name Time Method Number of patients with BSI or severe blood culture negative infection ≤ 6 months after randomization Each of the components in the primary endpoint
Mortality ≤ 6 months after randomization All-cause mortality
Trial Locations
- Locations (7)
Rigshospitalet
🇩🇰Copenhagen, Capital Region, Denmark
Herlev-Gentofte Hospital
🇩🇰Copenhagen, Capital Region, Denmark
Aalborg University Hospital
🇩🇰Aalborg, North Region, Denmark
ZUH Roskilde
🇩🇰Roskilde, Region Sjaelland, Denmark
Odense University Hospital
🇩🇰Odense, Region South, Denmark
North Zealand Hospital Hillerød
🇩🇰Hillerød, Capital Region, Denmark
Aarhus University Hospital
🇩🇰Aarhus, Middle Region, Denmark