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Study on Preventing Blood Infections in Hemodialysis Patients Using Amoxicillin/Clavulanic Acid or Clindamycin

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on patients with end-stage kidney disease who are undergoing hemodialysis, a treatment that helps clean the blood when the kidneys are not working well. These patients often use a central venous catheter (CVC) as a way to access their blood for dialysis. The study is investigating the use of prophylactic antibiotic treatment to prevent infections, specifically blood poisoning, which is a serious condition that can occur in these patients.

The trial will test two antibiotics: amoxicillin/clavulanic acid and clindamycin. Amoxicillin/clavulanic acid is the primary treatment, but clindamycin will be used for those who cannot tolerate beta-lactam antibiotics, a common type of antibiotic. The purpose of the study is to see if taking these antibiotics can reduce the risk of infections during the first six months after starting hemodialysis with a CVC.

Participants in the study will be randomly assigned to receive either the antibiotic treatment or a placebo. The study will last for six months, during which time the health of the participants will be monitored to see if the antibiotics help prevent infections. The goal is to find out if this approach can help reduce hospitalizations due to infections in patients with end-stage kidney disease who are receiving hemodialysis.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, participation is confirmed for individuals with end-stage kidney disease who are using a central venous catheter for hemodialysis.

    Eligibility is based on the use of either an uncuffed or cuffed central venous catheter for expected chronic hemodialysis.

  2. Step 2

    Randomization

    Participants are randomly assigned to receive either the antibiotic treatment or a placebo. This process ensures that the study results are unbiased.

  3. Step 3

    Medication administration

    The study involves the administration of prophylactic antibiotics during hemodialysis sessions.

    Participants receive either amoxicillin/clavulanic acid or clindamycin if they are intolerant to beta-lactam antibiotics.

    Both medications are taken orally. Amoxicillin/clavulanic acid is provided in the form of film-coated tablets, while clindamycin is provided as hard capsules.

  4. Step 4

    Monitoring and follow-up

    Participants are monitored for any signs of blood poisoning or severe infections without positive blood cultures during the first six months after starting hemodialysis.

    The primary focus is on hospitalizations due to blood poisoning or infections lasting three or more days, with specific criteria for infection severity.

  5. Step 5

    Completion of study participation

    The study is expected to continue until December 31, 2027.

    Participants' involvement in the study concludes after the six-month monitoring period following randomization.

Who can join the trial?

5 criteria

  • Patients must have **End Stage Kidney Disease (ESKD)**, which means their kidneys are no longer working well enough to keep them healthy.
  • Patients should be receiving **hemodialysis (HD)**, a treatment that uses a machine to clean the blood when the kidneys can't do it.
  • Patients must have a **Central Venous Catheter (CVC)**, which is a tube placed in a large vein to allow access for hemodialysis.
  • Both **men and women** can participate in the study.
  • Patients of all ages are eligible, as there are no specific age restrictions mentioned.

Who cannot join the trial?

5 criteria

  • Patients who are not undergoing hemodialysis. Hemodialysis is a treatment that uses a machine to clean your blood when your kidneys are not working properly.
  • Patients who do not have a CVC as vascular access. CVC stands for Central Venous Catheter, which is a tube placed in a large vein to give treatments or draw blood.
  • Patients who are not within the specified age range for the study.
  • Patients who are part of a vulnerable population, which means they might need special protection or care.
  • Patients who are intolerant to beta-lactam antibiotics. Beta-lactam antibiotics are a group of antibiotics that include penicillin and similar medicines.
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Investigated drugs

  • Amoxicillin/Clavulanic Acid

    is an antibiotic used to prevent infections. In this trial, it is given to patients undergoing hemodialysis to help prevent bloodstream infections and other severe infections that might occur when using a central venous catheter for dialysis.

  • Clindamycin

    is another antibiotic used in this trial for patients who cannot take amoxicillin/clavulanic acid due to allergies or intolerance. It serves the same purpose of preventing infections in patients undergoing hemodialysis with a central venous catheter.

What is already known about the treatment

  • Amoxicillin/Clavulanic Acid

    This medication is administered orally or intravenously and is used to prevent infections in patients undergoing hemodialysis. It is currently being studied in clinical trials for its effectiveness in preventing blood infections in patients with end-stage kidney disease using central venous catheters. The main therapeutic indication is to prevent blood poisoning in these patients. At the molecular level, amoxicillin works by inhibiting bacterial cell wall synthesis, while clavulanic acid inhibits beta-lactamase enzymes, enhancing the antibiotic's effectiveness. It is classified as a combination antibiotic.

  • Clindamycin

    This medication is administered orally or intravenously and is used as an alternative for patients who are intolerant to beta-lactam antibiotics. It is being evaluated in clinical trials for its role in preventing blood infections in patients with end-stage kidney disease undergoing hemodialysis. The primary therapeutic indication is to prevent blood poisoning in these patients. Clindamycin works by inhibiting bacterial protein synthesis, thereby stopping bacterial growth. It is classified as a lincosamide antibiotic.

Investigated diseases

Sepsis – Sepsis is a severe and potentially life-threatening condition that arises when the body's response to infection causes injury to its own tissues and organs. It can progress rapidly, leading to widespread inflammation, blood clotting, and organ dysfunction. In patients with renal failure undergoing hemodialysis, the risk of sepsis is heightened due to the use of central venous catheters, which can introduce bacteria into the bloodstream. The condition can start with symptoms like fever, increased heart rate, and confusion, and may escalate to more severe symptoms if not managed promptly.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-515001-26-00Protocol code12020Estimated enrolment800 patientsSponsorRegion Sjaelland

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