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Study on the Safety and Absorption of Meropenem and Vaborbactam in Children with Complicated Urinary Tract Infections

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Wojskowy Instytut Medyczny Państwowy Instytut Badawczy
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Warsaw, Poland
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What is this trial about?

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

This clinical trial is focused on studying a medication called Vaborem, which is a combination of two substances: meropenem and vaborbactam. The study is aimed at children aged 3 months to less than 18 years who have a type of infection known as a complicated urinary tract infection (cUTI), which includes a condition called acute pyelonephritis. These infections are more severe and may require hospitalization and treatment with antibiotics given through a vein.

The purpose of the study is to understand how Vaborem is absorbed and tolerated in the body of children with these infections. Participants in the study will receive the medication through an intravenous infusion, which means it will be administered directly into the bloodstream. The study will monitor how the medication is processed in the body over a period of time, as well as any side effects that may occur. This will help determine the safety and effectiveness of the medication for treating these infections in children.

Throughout the study, researchers will collect information on how the medication affects the body, including measuring the levels of the drug in the blood at different times. They will also keep track of any changes in the participants' health, such as side effects or changes in laboratory test results. The study is designed to ensure that the medication is safe and well-tolerated by children with these types of infections.

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
Joining the study
Upon joining the study, informed consent must be provided by a parent or legal representative. If appropriate, the participant will also provide assent.
Participants must be between 3 months and less than 18 years old and require hospitalization for a complicated urinary tract infection (cUTI) or acute pyelonephritis (AP).
Step 2
Initial assessment
A urine specimen will be collected for culture using an acceptable method such as clean urethral catheterization or mid-stream clean catch. This must be done within 48 hours before starting the first dose of the study medication.
The presence of pyuria, indicated by white blood cells in the urine, will be confirmed.
Step 3
Medication administration
The study involves the administration of Vaborem, which contains the active substances meropenem and vaborbactam.
The medication is given through an intravenous infusion, which means it is delivered directly into the bloodstream through a vein.
The treatment requires a minimum of 3 days of intravenous antibiotic therapy, as determined by the investigator.
Step 4
Monitoring and evaluation
Throughout the study, various parameters will be monitored, including the concentration of the medication in the blood over time, maximum concentration levels, and how the body processes the drug.
Participants will be observed for any adverse events or changes in clinical laboratory values and vital signs.
Step 5
Completion of the study
The study is estimated to conclude by July 15, 2026.
Upon completion, the data collected will be analyzed to assess the safety and effectiveness of the medication in treating complicated urinary tract infections in the pediatric population.

Who can join the trial?

13 criteria

Provide written informed consent before starting any study-related procedures. This means that a parent or legal representative must agree to the study, and the child should also agree if they are old enough to understand.
Be a boy or girl aged between 3 months and less than 18 years old.
Need to stay in the hospital for a complicated urinary tract infection (cUTI) or acute pyelonephritis (AP) and require at least 3 days of intravenous (IV) antibiotic treatment, as decided by the doctor.
Show evidence of pyuria, which means having white blood cells in the urine. This can be shown by:
- A urine test that is positive for leukocyte esterase, which is a sign of white blood cells, or
- A urine sample with more than 10 white blood cells per microliter from unspun urine or more than 5 white blood cells per high power field from spun urine.
- Have current or suspected cUTI or AP, shown by certain signs and symptoms, and complicating factors:
  - For children aged 3 months to less than 2 years, signs can include fever, weight loss, abdominal pain, irritability, poor feeding, less activity, abdominal tenderness, vomiting, or jaundice.
  - For children aged 2 to less than 18 years, signs can include fever, painful urination, frequent urination, urgent need to urinate, inability to control urination, pain in the lower belly or sides, tenderness in the lower belly or back, nausea, or vomiting.
  - Complicating factors for all ages include:
    
    Not having a permanent urinary catheter or other urinary device.
    Using a urinary catheter occasionally.
    Having a known abnormality in the urinary system, which could be structural or functional.
    Having had two or more urinary tract infections in the past year.
    Having a current infection that might be caused by bacteria resistant to treatment, especially if the child is already on long-term antibiotics to prevent infections.
    Have a urine sample taken for testing before starting the study treatment. This sample must be collected in an approved way, such as through a clean catch or catheter, within 48 hours before the first dose of the study medication.

Who cannot join the trial?

3 criteria

Participants who are not between the ages of 3 months and less than 18 years.
Participants who do not have a **complicated urinary tract infection** (cUTI) or **acute pyelonephritis** (AP). A complicated urinary tract infection is a more serious type of infection in the urinary system, and acute pyelonephritis is a sudden and severe kidney infection.
Participants who are not able to receive multiple doses of the study medication through an **IV infusion**. An IV infusion is a way to deliver medicine directly into the bloodstream through a vein.

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Verified sites

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Wojskowy Instytut Medyczny Państwowy Instytut Badawczy
Verified & featuredResponsive
Warsaw, Poland
Recruiting
Azienda Ospedaliero Universitaria Parma
Responsive
Parma, Italy
Fakultni Nemocnice Kralovske Vinohrady
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Prague, Czechia

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Investigated drugs

Vaborem is a combination of two medications, meropenem and vaborbactam. It is used to treat complicated urinary tract infections, including a severe type called acute pyelonephritis. Meropenem is an antibiotic that helps kill bacteria causing the infection, while vaborbactam helps prevent certain bacteria from breaking down meropenem, making the treatment more effective. This study is focused on understanding how these medications work in children aged 3 months to less than 18 years.

What is already known about the treatment

Vaborem – This medication is administered through intravenous infusion and is currently being studied in clinical trials for its safety and effectiveness in children with complicated urinary tract infections, including acute pyelonephritis. Vaborem is a combination of two active ingredients, meropenem and vaborbactam, which work together to treat bacterial infections. Meropenem is a broad-spectrum antibiotic that disrupts bacterial cell wall synthesis, while vaborbactam inhibits enzymes that can degrade meropenem, enhancing its effectiveness. It is classified as a carbapenem antibiotic combined with a beta-lactamase inhibitor.

Investigated diseases

Complicated Urinary Tract Infection (cUTI)
This condition involves an infection in the urinary tract that is often associated with structural or functional abnormalities, making it more difficult to treat than a simple urinary tract infection. It can affect any part of the urinary system, including the bladder, urethra, ureters, and kidneys. Symptoms may include a strong, persistent urge to urinate, a burning sensation during urination, and cloudy or strong-smelling urine. In some cases, it can lead to more severe symptoms such as fever, chills, and flank pain. The progression of the disease can vary, but it often requires medical intervention to prevent complications.
Acute Pyelonephritis
This is a sudden and severe kidney infection that causes the kidneys to swell and can lead to permanent damage if not treated promptly. It typically starts as a urinary tract infection that spreads to the kidneys. Symptoms often include high fever, pain in the back or side, nausea, and vomiting. The condition can cause the kidneys to become inflamed, and if left untreated, it may lead to more serious health issues. The progression of acute pyelonephritis can be rapid, necessitating medical attention to manage symptoms and prevent further complications.