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Effect of Pivmecillinam vs Placebo on Enterobacterales Urinary Tract and Bloodstream Infections in High‑Risk Kidney Transplant Recipients (Months 1‑6)

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What is this trial about?

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

The study focuses on people who have undergone kidney transplantation, a procedure that replaces a failing kidney with a donor organ. After this surgery, patients are especially vulnerable to bacterial urinary tract infections (infections of the bladder or kidneys caused by bacteria) and bloodstream infections (bacteria that enter the blood). The trial compares a preventive (prophylactic) antibiotic called pivmecillinam with an inactive tablet known as placebo, with the purpose of determining whether the antibiotic lowers the number of these infections in the first six months after the transplant.

Participants will be randomly assigned to receive either the antibiotic pill (400 mg taken by mouth each day) or the placebo pill for six months following the transplant. Throughout this period, they will attend scheduled clinic visits where urine and blood samples are collected to check for signs of infection, to monitor kidney function (how well the new kidney works), and to assess overall health and quality of life. The study ends after the six‑month follow‑up, at which point the rates of infections in the two groups are compared.

The research process

The trial runs in 9 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Enrollment and consent

    After agreeing to participate, you sign a consent form that explains the study and your responsibilities.

  2. Step 2

    Baseline assessment (month 1 post‑transplant)

    At one month after your kidney transplant, study staff collect blood and urine samples, record your health status, and ask you to complete a quality of life questionnaire.

    The information serves as a reference point for later comparisons.

  3. Step 3

    Randomization to medication group

    Based on a computer‑generated list, you are assigned to receive either pivmecillinam or a matching placebo.

    The assignment is unknown to you and the staff who interact with you.

  4. Step 4

    Start of study medication

    You begin taking the study pill every day for six months, starting at month 1 post‑transplant.

    The active drug, pivmecillinam, is given as 400 mg taken orally once daily.

    If you are assigned to the placebo group, you take an identical‑looking pill containing no active medicine, also 400 mg once daily.

  5. Step 5

    Daily medication intake

    Each day you swallow the pill with water, preferably at the same time each day to keep the schedule consistent.

  6. Step 6

    Monthly follow‑up visits

    Every month until the end of month 6, you attend a clinic visit or a telephone check‑in.

    During these visits, staff ask about any signs of urinary tract infection or bloodstream infection, record side effects, and may collect additional blood or urine samples.

    The month 3 visit includes another set of blood samples for research purposes.

  7. Step 7

    Quality of life questionnaire (month 6)

    At the final month of medication, you complete a standardized questionnaire that measures your overall quality of life after transplantation.

  8. Step 8

    Final assessment and end of medication

    At month 6, the study medication is stopped.

    Staff review all collected data to determine whether you experienced any urinary tract infection, bloodstream infection, or other health events during the six‑month period.

    The results are recorded for the study analysis.

  9. Step 9

    Long‑term registry follow‑up (optional)

    Your health information may be linked to a national transplant registry for up to ten years to assess long‑term outcomes such as graft loss or mortality.

    Participation in this follow‑up does not require additional visits.

Who can join the trial?

4 criteria

  • You must be at least 18 years old.
  • You must have received a kidney transplant (a kidney from another person).
  • You must be able to sign a written form showing you understand the study and agree to take part, called written informed consent.
  • You must have had at least one urine test in the first month after your transplant that showed bacteriuria (bacteria in the urine) of at least 100,000 CFU/mL (the number of bacterial colonies that can grow from one milliliter of urine), and the test must not show any fungi (organisms such as yeast).

Who cannot join the trial?

10 criteria

  • Having a narrowed or blocked tube in the food pipe (esophagus) or a blockage in the stomach or intestines, including a condition called diabetes gastroparesis where the stomach empties very slowly.
  • Being pregnant or breastfeeding.
  • Being allergic to β‑lactam antibiotics, a common class of antibiotics.
  • Having a known or suspected genetic problem that affects how the body processes carnitine, such as a carnitine transporter defect or disorders called organic acidurias (for example, methylmalonic aciduria or propionic acidaemia).
  • Being of Faroese descent (both biological parents born in the Faroe Islands).
  • Having porphyria, a disorder that affects the production of certain blood pigments.
  • Currently taking valproic acid, valproate, or other medicines that release pivalic acid in the body.
  • Currently taking the medicine probenecid.
  • Currently taking the medicine methotrexate.
  • Needing dialysis (a treatment that cleans the blood) one month after the kidney transplant.
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Investigated drugs

Pivmecillinam is an oral antibiotic that was given to kidney transplant recipients in this study. The researchers wanted to see if taking this medicine for the first six months after the transplant could lower the chance of getting urinary tract infections or bloodstream infections caused by certain bacteria (Enterobacterales). Participants received the medication as a preventive measure, and the study compared infection rates between those who took the antibiotic and those who did not.

What is already known about the treatment

PLACEBO - The placebo is taken by mouth as a tablet that contains no active drug. It is used only as a control in the study and is not a medicine used in regular care. Because it has no active ingredient, it has no therapeutic effect or known mechanism. It is classified simply as an inert control substance. PIVMECILLINAM - Pivmecillinam is taken by mouth as a 400 mg tablet. It is an approved antibiotic used to treat urinary tract infections caused by bacteria and is being studied for preventing bloodstream infections after kidney transplant. The drug works by stopping bacteria from building their cell wall, which kills the bacteria. It belongs to the penicillin class of beta‑lactam antibiotics.

Investigated diseases

  • Enterobacterales urinary tract infection

    This infection occurs when bacteria belonging to the Enterobacterales order colonize the urethra and bladder. It often begins with mild discomfort or urgency to urinate. If the bacteria travel upward, they can involve the kidneys, causing more extensive inflammation. Repeated episodes can lead to chronic irritation of the urinary tract lining.

  • Enterobacterales bloodstream infection

    Bacteria from the Enterobacterales group enter the circulatory system, spreading throughout the body. The infection may start silently and then produce fever or chills as the immune system responds. As the bacteria multiply, they can affect multiple organs and cause systemic inflammation. Persistent presence in the blood can lead to ongoing immune activation.

  • Multidrug-resistant organism infection

    This condition is caused by bacteria that are resistant to several classes of antibiotics. The infection can arise in any body site, such as the urinary tract, skin, or respiratory system. Because standard antibiotics are less effective, the bacteria may continue to grow despite treatment attempts. Over time, the infection can become more widespread and harder to clear.

  • Clostridioides difficile infection

    This infection is caused by a toxin-producing bacterium that colonizes the colon after the normal gut flora is disturbed. It typically begins with watery diarrhea and abdominal cramping. The toxins damage the lining of the colon, leading to inflammation. If the inflammation persists, it can cause further disruption of bowel function.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2026-527337-63-00Estimated enrolment180 patientsSponsorRegion Hovedstaden

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