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Study of pivmecillinam compared to standard antibiotics for treating Escherichia coli urinary tract infection with fever

Fast replyRegistered 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 studies the treatment of febrile Urinary Tract Infection (fever with urinary infection) caused by Escherichia coli bacteria. The study compares two treatment approaches: one using pivmecillinam tablets and another using standard care medications. The infection being studied typically causes symptoms like fever, pain in the lower back or pelvis area, frequent urination, and discomfort while urinating.

The treatments used in this study include various antibiotics that can be given either through a vein (intravenous) or by mouth. Some of these medications are amoxicillin, ciprofloxacin, ceftriaxone, and several others. The study starts with giving antibiotics through a vein until the fever goes away and the patient's condition improves. Then, depending on which group the patient is assigned to, they will either receive pivmecillinam tablets or continue with standard treatment.

The study will check how well the treatments work by monitoring if symptoms improve, if the fever stays away, and if the infection clears up. The researchers will also look at side effects of the medications, how the treatments affect bacteria in the digestive system, and which treatment approach is more cost-effective. The study is expected to run for several years, starting in 2025.

The research process

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

Step 1
Initial treatment phase
You will receive intravenous antibiotics for at least 2 days to treat your urinary tract infection with fever.
Treatment will continue until your fever goes away and your condition is stable for at least 24 hours.
Step 2
Transition to oral medication
After your condition improves, you will be assigned to receive either pivmecillinam tablets (400 mg four times daily) or standard treatment.
The medication will be provided according to your assigned treatment group.
Step 3
First follow-up visit
You will have a check-up 7 days (plus or minus 2 days) after completing treatment.
During this visit, your symptoms will be evaluated and a urine sample will be collected.
You will be asked about any side effects you may have experienced.
Step 4
Second follow-up visit
A final check-up will occur 28 days (plus or minus 2 days) after completing treatment.
Another urine sample will be collected to ensure the infection has not returned.
Your overall recovery will be evaluated.
Step 5
Additional monitoring for selected participants
Some participants (60 in total) will be selected for additional tests:
30 participants will provide stool samples to study the effects of antibiotics on gut bacteria.
30 participants taking pivmecillinam will provide blood and urine samples to measure medication levels.

Who can join the trial?

12 criteria

Must be 18 years or older
Must have a fever of 38°C (100.4°F) or higher measured at a healthcare facility
Must have at least one of these symptoms:
- Flank pain (pain in the side of the body below the ribs)
- Pelvic pain (pain in the lower abdomen)
- Feeling sick to stomach or vomiting
- Dysuria (pain or burning when urinating)
- Frequent need to urinate or sudden urges to urinate
- Pain when the doctor presses on your back near the kidneys
- Must have a urine test showing E. coli bacteria that can be treated with the study medication (mecillinam)
- Must have received at least 2 days of appropriate intravenous (through the vein) antibiotics for the infection
- Must have no fever and stable vital signs (blood pressure, heart rate) for at least 24 hours, as determined by the doctor
- Must be willing and able to sign an informed consent form

Who cannot join the trial?

13 criteria

Age below 18 years old or above 65 years old
Known allergic reactions to antibiotics used in the study
Pregnancy or breastfeeding
Having other serious medical conditions that could affect the study results
Current participation in other clinical trials
Having taken antibiotics within 7 days before the study start
Known kidney failure (condition where kidneys don't work properly)
Having urinary tract abnormalities (unusual structure of urinary system)
Presence of urinary catheter (a tube used to drain urine)
History of recurrent urinary tract infections (3 or more infections in the past year)
Immunocompromised status (weakened immune system)
Unable to take oral medications
Unable to provide informed consent

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Verified sites

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Helse Bergen HF
Verified
Bergen, Norway
Karolinska University Hospital
Verified
Solna, Sweden
Region Vaesterbotten
Responsive
Umea, Sweden

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Investigated drugs

Pivmecillinam
is an antibiotic medication used to treat urinary tract infections. It works by stopping the growth of bacteria, specifically E. coli, that cause urinary tract infections with fever. This medication is taken by mouth and belongs to the penicillin family of antibiotics. It is commonly used in many European countries as a first-line treatment for urinary tract infections.
Standard of care antibiotics
refers to the currently accepted and commonly used antibiotic treatments for febrile urinary tract infections. These are the established treatments that doctors typically prescribe for this condition, which may include various types of antibiotics depending on local treatment guidelines and patient factors.

What is already known about the treatment

Pivmecillinam - An oral antibiotic medication administered in tablet form, specifically designed to treat urinary tract infections caused by Escherichia coli bacteria. This medication belongs to the penicillin group of antibiotics and works by interfering with bacterial cell wall synthesis, leading to the destruction of harmful bacteria. Pivmecillinam is particularly valued in clinical practice for its effectiveness against urinary tract pathogens and its ability to be used as a step-down therapy after initial intravenous antibiotic treatment, with a typical dosing schedule of 400 mg taken four times daily. The medication has gained significant attention in medical literature for its role in treating febrile urinary tract infections while offering the convenience of oral administration.

Investigated diseases

Febrile Urinary Tract Infection (fUTI) - A urinary tract infection accompanied by fever (temperature above 38°C/100.4°F). The condition occurs when bacteria, most commonly E. coli, travel up the urinary tract and cause infection in the bladder or kidneys. The infection triggers an inflammatory response in the body, leading to elevated body temperature and other symptoms such as frequent urination, burning sensation during urination, and lower back pain. In most cases, the infection begins in the lower urinary tract (bladder) and may spread to the upper urinary tract (kidneys). The presence of fever indicates that the infection has triggered a significant systemic response in the body.