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

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 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.

The research process

The trial runs in 3 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial treatment phase
One of three different antibiotic treatment plans is provided to treat a complicated urinary tract infection, which is an infection in the urinary system that requires hospital care.
If assigned to the first plan, a single intravenous dose (medicine delivered through a vein) of ampicillin at 8 grams is given, along with gentamicin at 5 mg/kg (a dose based on body weight) through a vein.
If assigned to the second plan, a single intravenous dose of piperacillin and tazobactam at 16 grams is given, along with gentamicin at 5 mg/kg through a vein.
If assigned to the third plan, a single intravenous dose of gentamicin at 5 mg/kg is given, followed by pivmecillinam taken by mouth at a dose of 800 mg, taken three times daily.
Step 2
Clinical assessment on day 3
On the third day of treatment, a clinical cure is assessed. this means checking if symptoms and fever have resolved, if there is clinical improvement, and if there is no need to increase the strength of the antibiotic therapy.
Step 3
Follow-up monitoring
Monitoring continues to track several outcomes, including mortality (death) at 30, 90, and 365 days.
The microbiological cure is checked on day 3 to see if the bacteria causing the infection are gone.
The time taken to switch to oral-only antibiotic therapy (medicine taken by mouth) is recorded.
The length of hospital stay and the total duration of antibiotic treatment are documented.
The occurrence of nephrotoxicity (damage to the kidneys) within 30 days is monitored.
Any serious adverse reactions related to the treatment are recorded.
The presence of secondary infections, such as C. difficile (a type of bacteria) or Candida (a type of fungus) in the genital or oral areas, is checked within 30 days.
hospital readmission due to a urinary tract infection is monitored for 90 days.
The use of antibiotic prescriptions for urinary tract infections after leaving the hospital is tracked for 90 days.

Who can join the trial?

4 criteria

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 trial?

14 criteria

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).

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Herlev Hospital
Verified
Herlev, Denmark
Hvidovre Hospital
Verified
Hvidovre, Denmark
Odense University Hospital
Verified
Odense, Denmark

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Investigated drugs

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.

What is already known about the treatment

Ampicillin
This medication is an antibiotic administered through an intravenous injection into a vein. It is a well-established treatment used widely in medicine to fight various bacterial infections. It works by preventing bacteria from building their protective cell walls, which eventually causes them to burst and die. It is classified as a penicillin-type antibiotic.
Gentamicin
This antibiotic is given through an intravenous injection to treat serious bacterial infections. It is a commonly used medication in hospitals that works by interfering with the protein-making machinery inside bacteria, effectively stopping them from growing. It belongs to a group of drugs known as aminoglycosides.
Pivmecillinam
This is an antibiotic taken orally in tablet form. It is an established treatment primarily used to manage urinary tract infections. At a molecular level, it works by disrupting the construction of the bacterial cell wall, leading to the death of the bacteria. It is classified as a penicillin-type antibiotic.
Piperacillin and tazobactam
This combination medication is administered through an intravenous injection. It is a widely used advanced treatment for severe or complicated bacterial infections. Piperacillin works by destroying the bacterial cell wall, while tazobactam protects the antibiotic from being broken down by the bacteria's defense mechanisms. This combination is classified as a penicillin antibiotic paired with a beta-lactamase inhibitor.

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.