Comparing pivmecillinam and gentamicin with standard treatments for hospitalized adults with complicated urinary tract infections

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What is this study about?

This study focuses on Complicated urinary tract infections, which are infections of the urinary system that are severe enough to require a stay in the hospital. The purpose of the study is to compare a new combination of medications to the standard treatments currently used in hospitals. One group will receive pivmecillinam taken by mouth and a single dose of gentamicin given through an intravenous line, which is a tube inserted into a vein to deliver medicine directly into the bloodstream. Another group will receive standard treatments consisting of either ampicillin combined with gentamicin, or a combination of piperacillin and tazobactam, both delivered through an intravenous line.

During the study, participants will be monitored to see how well the different antibiotic treatments work to clear the infection and reduce symptoms such as fever. The course of the study involves comparing the effectiveness of the oral and injection combination against the existing hospital methods to determine if the new approach is just as effective in achieving a clinical cure.

Who Can Join the Study?

  • You must be at least 18 years old.
  • You must be staying in the hospital.
  • You must have signs or symptoms of acute pyelonephritis, which is a sudden kidney infection, or a lower complicated urinary tract infection, which is a serious infection in the bladder or urethra.
  • Your doctor must have already planned to give you intravenous antibiotics, which are medicines used to fight infection that are delivered directly into a vein through a needle or tube.

Who Cannot Join the Study?

  • A score of 2 or higher on the quick Sequential Organ Failure Assessment (qSOFA), which is a tool used to check for signs of severe infection or organ failure based on fast breathing, changes in mental clarity, or low blood pressure.
  • A known diagnosis of myasthenia gravis, which is a disease that causes weakness in the muscles.
  • Having acute mononucleosis (a viral infection often called “mono”) or porphyria (a group of rare disorders that affect the production of substances needed for blood cells).
  • Having pre-existing complicated urogenital conditions, which means existing health problems related to the urinary or reproductive organs.
  • Having received treatment with cisplatin or carboplatin, which are specific types of chemotherapy drugs.
  • Having ancestors from the Faroe Islands unless you have already been tested and found not to have Carnitine Transporter Deficiency (CTD), a condition that affects how the body uses energy.
  • Having received intravenous (IV) antibiotics to treat a complicated urinary tract infection before joining the study.
  • Being a recipient of a kidney transplant or using hemodialysis or peritoneal dialysis (methods used to clean the blood when the kidneys are not working properly).
  • Being unable to provide informed consent, which is the formal agreement to participate after understanding all the details of the study.
  • Having an estimated Glomerular Filtration Rate (eGFR) of less than 30ml/min/1.73m^2, which is a measure of how well your kidneys are filtering waste from your blood.
  • A urine culture performed within the last 72 hours that shows a germ that is resistant, meaning it is not killed, by the medicines being studied.
  • A known allergy or hypersensitivity to pivmecillinam, penicillins, cephalosporins, aminoglycosides, or any excipients (inactive ingredients used to make up a pill).
  • Being pregnant or breastfeeding.
  • Being unable to swallow or take oral medication (medicine taken by mouth).

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Sydvestjysk Sygehus Esbjerg Denmark

Other Sites

Site Name City Country Status
Odense University Hospital Odense Denmark
Sygehus Lillebaelt Vejle Sygehus Vejle Denmark
Sygehus Soenderjylland Soenderborg Aabenraa Denmark
Hsamqr Hbzvkftl Herlev Denmark
Htnyaqqf Huizyaes Hvidovre Denmark

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Denmark Denmark
Recruiting
05.01.2026

Trial locations

Gentamicin is an antibiotic used to treat various bacterial infections. In this study, it is used as part of a combination therapy to help fight the infection.

Pivmecillinam is an antibiotic taken by mouth to treat urinary tract infections.

Ampicillin is an antibiotic given through a vein to treat bacterial infections.

Piperacillin and tazobactam is a combination of two medicines given through a vein to treat serious bacterial infections.

Investigated diseases:

Complicated urinary tract infection – This condition occurs when an infection in the urinary system is accompanied by factors that increase the risk of spreading or becoming harder to manage. It involves the presence of bacteria in the kidneys, bladder, or urethra, often alongside other health issues. The infection can progress from a local irritation to a more systemic issue if the bacteria move from the lower urinary tract to the kidneys. Symptoms typically include pain, fever, and changes in urination patterns. If left unmanaged, the infection may spread further into the body.

Trial ID:
2024-520251-24-00
Trial Phase:
Therapeutic confirmatory (Phase III)

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