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

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What is this study about?

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.

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.

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.

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.

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.

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 Study?

  • 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 Study?

  • 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

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Oslo Universitetssykehus HF Oslo Norway

Other Sites

Site Name City Country Status
Region Oerebro Laen Orebro Sweden
Region Vaesterbotten Umea Sweden
Region Vaesternorrland Sundsvall Sweden
Soedra Aelvsborg Hospital Vaestra Goetalandsregionen Boras Sweden
Region Blekinge Karlskrona Sweden
Region Skane Skanes Universitetssjukhus Lund Sweden
Karolinska University Hospital Solna Sweden
Malarsjukhuset Eskilstuna Eskilstuna Sweden
Region Kronoberg Vaxjo Sweden
Queen Silvia Childrens Hospital – Sahlgrenska University Hospital – Vaestra Goetalandsregionen Gothenburg Sweden
Ulripkb Uditrygazz Hsgeiobz Uppsala Sweden
Hnpzo Bhxkju Hq Bergen Norway

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

Trial status

Country Status Recruitment Start
Norway Norway
Not yet recruiting
01.09.2025
Sweden Sweden
Recruiting
01.09.2025

Trial locations

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.

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.

Trial ID:
2023-503447-33-00
Protocol code:
PIVOT
Trial Phase:
Therapeutic exploratory (Phase II)

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