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NCT Number: NCT05248620

Prophylactic Antibiotic Treatment in Hemodialysis

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Herlev-Gentofte Hospital, Copenhagen, Capital Region, Denmark

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Amoxicillin Clavulanic 500/125mg or placebo

Drug

Prophylactic antibiotic treatment

Other names: Aurobindo

Primary outcomes

  1. Number of patients with Blood stream infection (BSI)

    Time frame: ≤ 6 months after randomization

    Hospitalization for BSI

  2. Number of patients with Severe blood culture negative infection

    Time frame: ≤ 6 months after randomization

    Hospitalization ≥ 3 days due to infection defined as: C-reactive protein (CRP) ≥ 75 and negative blood cultures, treated with iv antibiotics

Secondary outcomes

  1. Number of patients with BSI or severe blood culture negative infection

    Time frame: ≤ 6 months after randomization

    Each of the components in the primary endpoint

  2. Mortality

    Time frame: ≤ 6 months after randomization

    All-cause mortality

Other outcomes

  1. Number of patients with Sepsis

    Time frame: ≤ 6 months after randomization

    Hospitalization due to sepsis or septic shock

  2. Number of patients with Deep tissue infection

    Time frame: ≤ 6 months after randomization

    Infective endocarditis, osteomyelitis, and spondylodiscitis

  3. Number of patients with Autoinfection

    Time frame: ≤ 6 months after randomization

    Frequency of BSI autoinfection

  4. Number of patients with Clostridium difficile infection

    Time frame: ≤ 6 months after randomization

    Clostridium difficile infection - numbers and days of admission

  5. Mortality due to infection - number of patients

    Time frame: ≤ 6 months after randomization

    Mortality due to infection

  6. Number of CVC removals

    Time frame: ≤ 6 months after randomization

    CVC removal due to CVC infection

  7. Use of Antibiotics in Difined Daily Doses

    Time frame: ≤ 6 months after randomization

    Total use of antibiotics in Defined Daily Doses

  8. Healt-care economics

    Time frame: ≤ 6 months after randomization

    Health-care related economic consequences due to hospitalization and treatment of the disease

  9. Number of patients with Extended Spectrum Beta-Lactamase (ESBL) infection

    Time frame: ≤ 6 months after randomization

    ESBL infections - number of patients and days of admission

  10. Number of patients with Methicillin-resistant Staphylococcus aureus (MRSA) infection

    Time frame: ≤ 6 months after randomization

    MRSA infections - number of patients and days of admission

  11. Number of patients with Carbapenemase-Producing Organisms (CPO) infection

    Time frame: ≤ 6 months after randomization

    CPO infections - number og patients and days of admission

  12. Number of patients with Vancomycin-resistant enterococci (VRE) infection

    Time frame: ≤ 6 months after randomization

    VRE infections - number of patients and days of admission

  13. Number of patients with Cardiovascular events

    Time frame: ≤ 6 months after randomization

    Hospitalization with acute myocardial infarction, worsening heart failure or stroke

Study contacts

Contact information is provided by the study sponsor or research team.

Kasper K Iversen, Professor

CONTACT

[email protected]

Niels E Bruun, Professor

CONTACT

[email protected]

+4525159309

Sponsors and collaborators

Lead sponsor

Zealand University Hospital

Other

Registry information

Official study title

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

Acronym: PANTHEM

Important dates

Study start
2022
Primary completion
2028
Study completion
2029
First posted
Feb 21, 2022
Registry last updated
Jan 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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