Prophylactic Antibiotic Treatment in Hemodialysis

Prophylactic Antibiotic Treatment in End Stage Kidney Disease and Central Venous Catheter as Hemodialysis Vascular Access

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05248620

Acronym

PANTHEM

Enrollment

800

Registered

2022-02-21

Start date

2022-02-14

Completion date

2029-05-01

Last updated

2026-09-10

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

Conditions

Hemodialysis

Keywords

Blood stream infections, Severe culture negative infections, Central venous catheter, Hemodialysis, Antibiotic prophylaxis

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.

Interventions

DRUGAmoxicillin Clavulanic 500/125mg or placebo

Prophylactic antibiotic treatment

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

TRIPLE (Subject, Caregiver, Outcomes Assessor)

Masking description

Amoxicillin/placebo is provided in identical containers. Amoxicillin and placebo tablets are looking similar, but by decision of the Danish Medicines Agency amoxicillin tablets must not be removed from the original folio packing prior to use. Clindamycin active and placebo tablets look similar (incapsulated), and are provided in identical containers. Study medicine will be provided by 1-2 nurses at each site, who are unblinded. The patients and care providers are blinded

Intervention model description

Multicenter, randomized, single-blinded, placebo controlled study, with blinded endpoint evaluation

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Number of patients with Blood stream infection (BSI)	≤ 6 months after randomization	Hospitalization for BSI
Number of patients with Severe blood culture negative infection	≤ 6 months after randomization	Hospitalization ≥ 3 days, or dies within 3 days, due to infection defined as: C-reactive protein (CRP) ≥ 75 and negative blood cultures, treated with iv antibiotics

Secondary

Measure	Time frame	Description
Number of patients with BSI or severe blood culture negative infection	≤ 6 months after randomization	Each of the components in the primary endpoint
Mortality	≤ 6 months after randomization	All-cause mortality

Countries

Denmark

Contacts

CONTACTNiels E Bruun, Professor

nbru@regionsjaelland.dk+4525159309

CONTACTKasper K Iversen, Professor

Kasper.Karmark.Iversen@regionh.dk

PRINCIPAL_INVESTIGATORNiels E Bruun, Professor

Dept. cardiology, Zealand University Hospital, Roskilde, Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 11, 2026