Prophylactic Antibiotic Treatment in Hemodialysis

Zealand University Hospital800 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Enrollment

800

Conditions

Hemodialysis

Interventions

Amoxicillin Clavulanic 500/125mg or placeboDRUG

Prophylactic antibiotic treatment

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (7)

Rigshospitalet

Copenhagen, Capital Region, Denmark

NOT_YET_RECRUITING

Herlev-Gentofte Hospital

Copenhagen, Capital Region, Denmark

RECRUITING

North Zealand Hospital Hillerød

Hillerød, Capital Region, Denmark

Outcomes

Primary Outcomes

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 due to infection defined as: C-reactive protein (CRP) ≥ 75 and negative blood cultures, treated with iv antibiotics

Time frame: ≤ 6 months after randomization

Secondary Outcomes

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

Central Contacts

Niels E Bruun, Professor

CONTACT

+4525159309 nbru@regionsjaelland.dk

Kasper K Iversen, Professor

CONTACT

Kasper.Karmark.Iversen@regionh.dk

Data from ClinicalTrials.gov

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