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Study on Cefepime and Enmetazobactam for Children with Complicated Urinary Tract Infections, Including Acute Pyelonephritis

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 clinical trial is focused on studying the treatment of complicated urinary tract infections (cUTI), including a type of kidney infection known as acute pyelonephritis. The treatment being tested is a combination of two medications: cefepime and enmetazobactam. Enmetazobactam is also known by the code name AAI101. These medications are given together as a solution through an intravenous infusion, which means they are delivered directly into the bloodstream over a period of two hours.

The purpose of this study is to understand how the body processes these medications, as well as to assess their safety and how well they are tolerated by patients. The study involves participants from birth up to 18 years of age who are hospitalized with cUTI, including acute pyelonephritis. During the study, participants will receive the medication through an intravenous infusion, and their health will be monitored closely to observe how their bodies respond to the treatment.

Participants will be observed for any side effects or changes in their health, and various tests will be conducted to gather information about the medication's effects. The study aims to provide valuable insights into the use of cefepime and enmetazobactam in treating complicated urinary tract infections in children and adolescents.

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, you will be required to provide written informed consent from your parent or legal representative. If you are old enough, you may also need to give your own agreement to participate.
You will need to have sufficient access to your veins to receive the study medication through an intravenous infusion.
Step 2
Initial assessment
A healthcare professional will assess your medical condition to confirm that you have a complicated urinary tract infection, which may include acute pyelonephritis. This assessment will determine if you need to be hospitalized for treatment with intravenous therapy.
A urine sample will be collected within 48 hours before you receive the first dose of the study medication. This sample will help identify the bacteria causing the infection.
Step 3
Medication administration
You will receive the study medication, cefepime-enmetazobactam, through an intravenous infusion. This means the medication will be delivered directly into your bloodstream through a vein.
The infusion will last for 2 hours. The dosage and frequency will be determined by the healthcare team based on your specific needs.
Step 4
Monitoring and follow-up
Throughout the study, your health will be closely monitored. This includes regular checks of your vital signs, laboratory tests, and physical examinations to ensure your safety and to observe how your body responds to the medication.
You will be observed for any side effects or adverse reactions to the medication. This includes monitoring for symptoms such as diarrhea, allergic reactions, or changes in liver function.
Step 5
Completion of the study
Once the treatment period is over, a final assessment will be conducted to evaluate the overall success of the treatment. This includes both clinical and microbiological evaluations to determine if the infection has been successfully treated.
You will receive guidance on any necessary follow-up care or precautions to take after the study concludes.

Who can join the trial?

14 criteria

Participant must be from birth to less than 18 years of age. If the participant is up to 2 months old, they must have been born at term or preterm with a gestational age of at least 32 weeks.
Participant must have enough access to their veins (either through a small needle in the arm or a central line) to receive the study treatment.
Written informed consent must be provided by the participant's parent(s) or legally acceptable representative(s). If the participant is old enough, they must also give their agreement to participate.
If the participant is female and has started menstruating or has reached a certain stage of physical development (Tanner stage 3), they must meet the following conditions:
- Have a negative pregnancy test at the screening visit.
- Agree to avoid becoming pregnant from the time of screening until 7 days after the study treatment ends.
- Report sexual abstinence for the prior 3 months or use at least one acceptable method of contraception, or agree to start sexual abstinence from the time of screening until 7 days after the study treatment ends.
- Participant must have a suspected or confirmed complicated urinary tract infection (cUTI) or acute pyelonephritis that requires hospitalization for treatment with intravenous (i.v.) therapy.
- The infection-causing bacteria must be confirmed or suspected to be treatable with the study medication, cefepime-enmetazobactam, according to the investigator's judgment.
- Participant must have pyuria, which means having a certain number of white blood cells in the urine, indicating infection:
  - If 1 year or older: More than 10 white blood cells per microliter in unspun urine or more than 10 cells per high power field in spun urine.
  - If younger than 1 year: More than 5 white blood cells per microliter in unspun urine or more than 5 cells per high power field in spun urine.
  - Participant must show clinical signs and/or symptoms of either acute pyelonephritis or cUTI at the screening visit, such as:
    
    For pyelonephritis, at least 2 new or worsening signs/symptoms like fever, irritability, poor feeding, or abdominal pain.
    For cUTI, at least 2 new or worsening signs/symptoms and at least 1 complicating factor like obstructive uropathy or a temporary urinary catheter.
    A urine sample must be collected within 48 hours before the first dose of the study treatment. The sample can be collected through various methods like a clean catch or catheterization.
    Participant must be likely to survive the current illness or hospitalization.

Who cannot join the trial?

1 criterion

Patients with **complicated urinary tract infections** that include **acute pyelonephritis** cannot participate. Acute pyelonephritis is a sudden and severe kidney infection.

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Verified sites

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

Fakultni Nemocnice Hradec Kralove
Verified
Novy Hradec Kralove, Czechia
Fundacion Para La Investigacion Biomedica Del Hospital Universitario La Paz
Responsive
Madrid, Spain
Hospital Clinico San Carlos
Verified
Madrid, Spain

Trial locations

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Investigated drugs

Cefepime-Enmetazobactam is a combination of two medications used to treat complicated urinary tract infections, including a type called acute pyelonephritis. Cefepime is an antibiotic that helps kill bacteria causing the infection, while Enmetazobactam enhances the effect of Cefepime by preventing bacteria from breaking it down. This combination is given through an intravenous infusion, which means it is delivered directly into the bloodstream through a vein, allowing it to work quickly and effectively in the body. The study aims to understand how this combination works in children and teenagers, focusing on its safety and how well it is tolerated by patients.

What is already known about the treatment

Cefepime-Enmetazobactam – This medication is administered through an intravenous infusion, meaning it is given directly into a vein over a period of two hours. It is currently being studied in a Phase 2 clinical trial to assess its safety, tolerability, and how it moves through the body in children from birth to under 18 years old who are hospitalized with complicated urinary tract infections, including a severe kidney infection called acute pyelonephritis. The main purpose of this medication is to treat these complicated infections by targeting and killing the bacteria causing them. Cefepime-Enmetazobactam belongs to a class of drugs known as antibiotics, which are used to fight bacterial infections.

Investigated diseases

Complicated urinary tract infections including acute pyelonephritis – Complicated urinary tract infections (cUTIs) are infections that occur in the urinary tract and are often associated with structural or functional abnormalities. These infections can affect the bladder, kidneys, or both, and are more severe than simple urinary tract infections. Acute pyelonephritis is a type of cUTI that specifically involves inflammation of the kidney due to bacterial infection. The disease progresses as bacteria ascend from the lower urinary tract to the kidneys, causing symptoms such as fever, chills, and flank pain. If not managed, the infection can lead to further complications, including kidney damage. The progression of cUTIs can vary depending on the underlying cause and the individual's health status.