HEMODIALYSIS AND ANTIBIOTIC PROPHYLAXIS

Phase 1

Conditions: Severe infection in patients end stage kidney disease and in hemodialysis with CVC as vascular asscess.
MedDRA version: 20.0Level: LLTClassification code 10023420Term: Kidney failure chronicSystem Organ Class: 100000004857
Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

Registration Number: EUCTR2020-001033-12-DK

Lead Sponsor: iels Eske Bruun

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 800

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

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 300
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 500

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.
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 clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: 1.In a randomised placebo-controlled trial to evaluate the effect of prophylactic antibiotic treatment with amoxicillin/clavulanic acid (or clindamycin if beta-lactam intolerant), administered in relation to the HD procedure on: BSI and severe blood culture negative infection, during the first 6 months after initiation of hemodialysis with CVC as vascular access. <br><br>;Secondary Objective: To compare the bacterial genome from pathogens isolated from blood samples with the genome of pathogens in the patient’s own microbiota, in HD patients with BSI and CVC as vascular access.;Primary end point(s): •Hospitalization for BSI = 6 months after randomization<br>•Hospitalization = 3 days due to infection defined as: CRP = 75 and negative blood cultures, treated with iv antibiotics, and occurring = 6 months after randomization<br>;Timepoint(s) of evaluation of this end point: After 6 months

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): •Each of the components in the primary endpoint<br>•All-cause mortality<br>;Timepoint(s) of evaluation of this end point: After 6 months