HEMODIALYSIS AND ANTIBIOTIC PROPHYLAXIS

PROPHYLACTIC ANTIBIOTIC TREATMENT IN END-STAGE KIDNEY DISEASE AND CENTRAL VENOUS CATHETER AS HEMODIALYSIS VASCULAR ACCESS

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-001033-12-DK

Enrollment

800

Registered

2020-04-17

Start date

2020-10-13

Completion date

Unknown

Last updated

2024-08-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Severe infection in patients end stage kidney disease and in hemodialysis with CVC as vascular asscess. MedDRA version: 20.0 Level: LLT Classification code 10023420 Term: Kidney failure chronic System Organ Class: 100000004857

Interventions

Trade Name: Amoxicillin/Clavulan syre Pharmaceutical Form: Tablet Pharmaceutical form of the placebo: Capsule Route of administration of the placebo: Oral use Trade Name: Clindamycin Pharmaceutical F

Eligibility

Sex/Gender

All

Inclusion 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 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

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

Design outcomes

Primary

Measure	Time frame
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. ;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 •Hospitalization = 3 days due to infection defined as: CRP = 75 and negative blood cultures, treated with iv antibiotics, and occurring = 6 months after randomization ;Timepoint(s) of evaluation of this end point: After 6 months	—

Measure

Time frame

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. ;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 •Hospitalization = 3 days due to infection defined as: CRP = 75 and negative blood cultures, treated with iv antibiotics, and occurring = 6 months after randomization ;Timepoint(s) of evaluation of this end point: After 6 months

—

Secondary

Measure	Time frame
Secondary end point(s): • Each of the components in the primary endpoint • All-cause mortality ;Timepoint(s) of evaluation of this end point: After 6 months	—

Countries

Denmark

Contacts

Public ContactResearch Unit Dept. Cardiology

ZUH Roskilde

pmja@regionsjaelland.dk

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026