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Testing Personalized Antibiotic Treatment with Amoxicillin and Clavulanic Acid for Children with Febrile Urinary Tract Infections

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 study involves children with Urinary Tract Infections who have fever. A urinary tract infection is an infection that affects parts of the body that make and carry urine, such as the bladder or kidneys. The treatment being used in this study is Augmentin Fruit, which contains two active substances called amoxicillin and clavulanic acid. This medication is an antibiotic, which means it helps fight bacterial infections. The medicine comes as a powder that is mixed with water to make a liquid suspension that can be swallowed.

The purpose of this study is to find out if giving the antibiotic for a shorter period of time works just as well as the usual longer treatment. Specifically, the study will compare giving the antibiotic for 24 hours after the fever goes away versus giving it for the standard 10 days. The study will check if the shorter treatment is as good as the longer treatment by looking at whether the infection comes back within 30 days after stopping the antibiotic. An infection coming back means that signs and symptoms of the urinary tract infection with fever appear again and tests confirm the presence of bacteria in the urine.

During the study, children will be randomly assigned to receive either the shorter or the standard length of antibiotic treatment. The maximum daily amount of the medication that can be given is 3 grams, and the maximum total amount over the entire treatment period is 30 grams. After treatment ends, children will be monitored through follow-up visits where doctors will check for any signs that the infection has returned. The study will also look at how well the treatment works in the short term and whether bacteria that are resistant to the antibiotic appear after treatment.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial diagnosis and enrollment

    Your child will be diagnosed with a urinary tract infection (an infection affecting the bladder or kidneys) based on a fever of at least 38°C and a positive urine test.

    The diagnosis will be confirmed by a urine culture, which is a laboratory test that identifies the bacteria causing the infection.

    Your child must be between 3 months and 3 years of age to participate in this trial.

  2. Step 2

    Random assignment to treatment group

    Your child will be randomly assigned to one of two treatment groups. This means that chance will determine which treatment duration your child receives.

    One group will receive antibiotic treatment for a shorter duration (24 hours after fever resolves), while the other group will receive the standard 10-day treatment.

  3. Step 3

    Antibiotic treatment

    Your child will receive amoxicillin and clavulanic acid (brand name Augmentin Fruit) as an oral suspension (liquid medicine taken by mouth).

    The dosage is 400 mg/57 mg per 5 ml.

    If your child is assigned to the shorter treatment group, the antibiotic will be given until 24 hours after the fever has resolved.

    If your child is assigned to the standard treatment group, the antibiotic will be given for a total of 10 days.

    The specific frequency of doses will be determined by the treating physician according to standard medical practice.

  4. Step 4

    Monitoring during treatment

    Your child's temperature will be monitored to determine when the fever has resolved.

    Clinical assessment will be performed to evaluate how your child is responding to the treatment.

  5. Step 5

    Follow-up period

    After the antibiotic treatment ends, your child will be monitored for 30 days.

    During this period, clinical assessments and urine tests will be performed to check for any return of infection symptoms.

    If symptoms of urinary tract infection reappear during this time, a urine test and urine culture will be performed to check for infection recurrence.

  6. Step 6

    Assessment of treatment outcomes

    The main outcome being measured is whether the infection returns within 30 days after treatment ends.

    The trial will also evaluate how well the treatment worked in the short term and whether bacteria resistant to the antibiotic have developed.

Who can join the trial?

7 criteria

  • The child must be between 3 months and 3 years old
  • The child must have a clinical diagnosis of febrile urinary tract infection, which means an infection in the urinary system with fever of 38 degrees Celsius or higher
  • The child must have a positive result on urinalysis, which is a urine test that checks for signs of infection such as nitrite (a substance produced by certain bacteria) or leukocyte esterase (a marker showing white blood cells in the urine that fight infection)
  • The urine sample must be collected following proper guidelines to ensure accurate results
  • The diagnosis must be confirmed by a positive urine culture, which is a laboratory test that grows bacteria from the urine sample to identify the specific type of bacteria causing the infection
  • The urine culture must show a single type of bacteria with a count greater than 100,000 colony forming units per milliliter, or greater than 10,000 colony forming units per milliliter if the sample was collected using a bladder catheterization (a thin tube inserted into the bladder to collect urine)
  • Parents must sign an informed consent form, which means they agree to allow their child to participate in the study after receiving all necessary information

Who cannot join the trial?

1 criterion

  • The exclusion criteria for this clinical trial have not been specified in the available information
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Investigated drugs

Amoxicillin and clavulanic acid is a combination antibiotic medication used to treat bacterial infections. Amoxicillin works by killing bacteria, while clavulanic acid helps the amoxicillin work better by preventing certain bacteria from becoming resistant to it. In this study, this antibiotic is being used to treat urinary tract infections in children who have a fever. The study is comparing two different lengths of treatment with this medication to see which works better.

What is already known about the treatment

Amoxicillin and Clavulanic Acid – This medication is a combination antibiotic taken by mouth, typically in tablet or liquid form, used to treat bacterial infections including urinary tract infections in children. It works by combining amoxicillin, which stops bacteria from building their protective cell walls, with clavulanic acid, which prevents bacteria from breaking down the amoxicillin, making the treatment more effective. This antibiotic is widely approved and commonly prescribed in medical practice for various bacterial infections. In this clinical trial, researchers are studying whether a shorter treatment duration based on fever resolution is as effective as the standard 10-day treatment course for urinary tract infections in children.

Investigated diseases

Urinary Tract Infections – Urinary tract infections are bacterial infections that affect any part of the urinary system, including the kidneys, bladder, ureters, or urethra. The infection occurs when bacteria, most commonly from the digestive tract, enter the urinary system through the urethra and begin to multiply. Common symptoms include a strong, persistent urge to urinate, a burning sensation when urinating, passing frequent small amounts of urine, and cloudy or strong-smelling urine. In febrile urinary tract infections, the infection causes fever and may indicate that the infection has reached the kidneys. The condition can cause pain in the lower abdomen or back, and the urine may appear red or pink if blood is present. Without proper care, the infection may recur or spread to other parts of the urinary system.
Trial detailsLast updated 7 Oct 2026
Age0-17PhasePhase IIITrial ID2025-520622-38-00Protocol codeRC 4/24 TREAT-UTIEstimated enrolment520 patientsSponsorIstituto Di Ricovero E Cura A Carattere Scientifico Materno Infantile Burlo Garofolo

sourced from the EU Clinical Trials Register and site verification

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