Prophylactic Antibiotic Treatment in End Stage Kidney Disease and Central Venous Catheter as Hemodialysis Vascular Access
Overview
- Phase
- Not Applicable
- Intervention
- Amoxicillin Clavulanic 500/125mg or placebo
- Conditions
- Hemodialysis
- Sponsor
- Zealand University Hospital
- Enrollment
- 800
- Locations
- 7
- Primary Endpoint
- Number of patients with Blood stream infection (BSI)
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
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.
Investigators
Eligibility Criteria
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.
Arms & Interventions
Active
Amoxicillin/clavulanic acid 500/125mg, tablets, will be administered before each hemodialysis for 6 months
Intervention: Amoxicillin Clavulanic 500/125mg or placebo
Placebo
Placebo tablets, similar to the active drug, will be administered before each hemodialysis for 6 months
Intervention: Amoxicillin Clavulanic 500/125mg or placebo
Outcomes
Primary Outcomes
Number of patients with Blood stream infection (BSI)
Time Frame: ≤ 6 months after randomization
Hospitalization for BSI
Number of patients with Severe blood culture negative infection
Time Frame: ≤ 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 Outcomes
- Number of patients with BSI or severe blood culture negative infection(≤ 6 months after randomization)
- Mortality(≤ 6 months after randomization)