Prophylactic Antibiotic Treatment in Hemodialysis (PANTHEM)

Zealand University Hospital

Status: Enrolling

Conditions: Hemodialysis

Treatments: Drug: Amoxicillin Clavulanic 500/125mg or placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT05248620

H-20026735

Details and patient eligibility

About

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.

Full 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.

Enrollment: 800 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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800 participants in 2 patient groups, including a placebo group

Active

Active Comparator group

Description:

Amoxicillin/clavulanic acid 500/125mg, tablets, will be administered before each hemodialysis for 6 months

Treatment:

Drug: Amoxicillin Clavulanic 500/125mg or placebo

Placebo

Placebo Comparator group

Description:

Placebo tablets, similar to the active drug, will be administered before each hemodialysis for 6 months

Treatment:

Drug: Amoxicillin Clavulanic 500/125mg or placebo