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Study of meropenem-vaborbactam safety and effectiveness in children aged 3 months to 12 years with complicated urinary tract infection or acute pyelonephritis

Verified siteInvestigationalNo 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 children with complicated urinary tract infection and acute pyelonephritis (a serious kidney infection). The research evaluates a medication called Vabomere, which contains two active substances: meropenem and vaborbactam. This combination medication is given as a solution through an intravenous infusion (delivered directly into a vein).

The main purpose of this research is to examine how safe and well-tolerated Vabomere is when used in children aged between 3 months and 12 years who have these urinary tract infections. During the study, participants will need to stay in the hospital initially and receive the medication through an intravenous infusion for at least 3 days. The total treatment period may last between 7 to 14 days.

Throughout the study, doctors will monitor the children's health by checking their blood and urine samples, vital signs, and any side effects that may occur. They will also look at how the medication moves through the body and how well it works in treating the infection. The medication will be given at regular intervals, with careful attention to the appropriate dose for each child.

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 hospital admission
You will be admitted to the hospital for treatment of complicated urinary tract infection or acute pyelonephritis (kidney infection).
A urine sample will be collected through catheterization or clean catch method for laboratory testing.
If you cannot sense urinary symptoms due to spinal cord conditions, two urine samples will be taken at least 1 hour apart.
Step 2
Treatment initiation
You will receive Vabomere (meropenem-vaborbactam) through an intravenous infusion (IV line).
The initial IV treatment will last at least 3 days while you stay in the hospital.
The total treatment duration will be 7 to 14 days.
Step 3
Monitoring during treatment
Your blood samples will be collected to measure medication levels.
Regular checks of vital signs will be performed.
Laboratory tests will monitor your blood count, kidney and liver function.
Any side effects will be recorded and assessed.
Step 4
Assessment of treatment response
Your symptoms will be evaluated to determine if they have improved or resolved.
Additional urine samples will be collected to check if the infection has cleared.
If you had a positive blood culture at the start, new blood samples will confirm the infection has been eliminated.
Step 5
Follow-up period
After completing treatment, you will be monitored for any lasting effects.
Final laboratory tests will be performed to ensure return to normal values.
If you are of reproductive age, continue using effective birth control for 7 days after treatment ends.

Who can join the trial?

10 criteria

Age between 3 months and 12 years. Children aged 3 months to 1 year must have been born after 37 weeks of pregnancy
Parent or legal guardian must provide written consent, and child must provide assent if age-appropriate
Must have a suspected or confirmed complicated urinary tract infection or kidney infection requiring at least 3 days of hospital treatment with intravenous antibiotics
Must show signs of urinary infection through a urine test showing either: - Positive test for white blood cells, or - More than 10 white blood cells per microliter in fresh urine, or - More than 5 white blood cells under microscope in processed urine
Must have at least two symptoms if age 2 or older: - Fever above 38°C - Pain during urination - Frequent urination - Urgent need to urinate - Pain in lower belly or side - Loss of bladder control - Feeling sick or vomiting
For children under 2 years, must have at least two symptoms: - Fever above 38°C - Poor growth - Weight loss - Irritability - Yellow skin color - Belly pain - Vomiting - Poor feeding - Unusual sleepiness
Must have at least one complicating factor, such as: - Urinary catheter - Recent urinary tract surgery - Abnormal urinary tract structure - History of repeated urinary infections
Must provide proper urine sample for testing before starting treatment
Must need 7-14 days of antibiotic treatment
For adolescents who have reached puberty, must agree to practice abstinence or use highly effective birth control during the study and for 7 days after

Who cannot join the trial?

15 criteria

Age less than 3 months or more than 12 years
Known allergy or severe reaction to Vabomere or similar antibiotics
Severe kidney problems that would affect the medication clearance
Currently taking medications that could interact with Vabomere
Presence of conditions that would interfere with study procedures
History of significant medical conditions that could affect study results
Participation in another clinical trial within past 30 days
Inability to receive intravenous (through the vein) medication
Pregnancy or breastfeeding
Urinary tract abnormalities that would require surgical intervention
Current use of other antibiotics that could affect study results
Severe infection requiring intensive care unit treatment
Known resistance to study medication
Unable to comply with study visits and procedures
History of recurring urinary tract infections that required long-term antibiotic treatment

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Verified sites

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Katholieke Universiteit te Leuven
Responsive
Leuven, Belgium
Nosokomeio Paidon I Agia Sofia
Responsive
Athens, Greece
University Multiprofile Hospital For Active Treatment Saint Georgi EAD
Responsive
Plovdiv, Bulgaria

Trial locations

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Investigated drugs

Vabomere (meropenem-vaborbactam) is an intravenous antibiotic medication used to treat complicated urinary tract infections, including kidney infections (acute pyelonephritis). It combines two active substances that work together: meropenem (which kills bacteria) and vaborbactam (which helps meropenem work better by preventing bacteria from becoming resistant to it). The medication is given through a vein (intravenous infusion).

What is already known about the treatment

Vabomere - A combination antibiotic medication containing meropenem and vaborbactam, administered through intravenous (IV) infusion for treating complicated urinary tract infections and acute pyelonephritis. This medication belongs to the carbapenem class of antibiotics combined with a beta-lactamase inhibitor, working by preventing bacteria from breaking down the antibiotic and stopping bacterial cell wall synthesis. The drug has been studied in clinical trials for pediatric patients aged 3 months to 12 years, representing an important treatment option for serious bacterial infections when other antibiotics may not be effective.

Investigated diseases

Complicated Urinary Tract Infection (cUTI)
A serious infection affecting any part of the urinary system that is accompanied by structural or functional abnormalities. This condition occurs when bacteria enter and spread through the urinary tract, causing inflammation and infection. The infection is considered "complicated" when there are factors that make the infection more difficult to treat, such as underlying medical conditions or anatomical abnormalities.
Acute Pyelonephritis (AP)
An infection of the kidney tissue and the renal pelvis that develops rapidly. The condition typically begins in the lower urinary tract and moves upward to affect one or both kidneys. It causes inflammation of the kidney tissue and can result in kidney swelling. The infection usually develops when bacteria from the lower urinary tract travel up through the ureters to the kidneys.