AuthorisedTherapeutic confirmatory (Phase III)Interventional

Personalized antibiotic TREATment for febrile Urinary Tract Infections in children (TREAT-UTI study): multicenter randomized controlled trial

This research is looking into better ways to treat urinary tract infections (UTIs) in children that cause a fever. It focuses on a specific medicine called Augmentin, given as a fruit-flavoured liquid. The main goal is to check how often the infection comes back within a month after children finish their antibiotics. Researchers will also look at how effective the treatment is overall and if using antibiotics might lead to germs becoming resistant to this medicine. This is a large-scale study involving many different hospitals, aiming to find the best and most effective treatment for children with this type of UTI.

At a glance

Status

Authorised

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Istituto Di Ricovero E Cura A Carattere Scientifico Materno Infantile Burlo Garofolo

Enrolment target

520

Start

12 Feb 2026

Urinary Tract Infections

What is this study about?

This study, called the TREAT-UTI study, is looking at how best to treat urinary tract infections (UTIs) in children, especially those infections that cause a fever. UTIs can be quite uncomfortable and concerning for children and their families, so finding the most effective treatment is really important.

The researchers are focusing on a particular antibiotic medicine called Augmentin, which comes in a pleasant fruit-flavoured liquid. They want to see if giving this medicine helps prevent the infection from returning shortly after a child finishes their course of antibiotics. They will also be checking how well children recover from their infection and if using antibiotics might make the germs that cause UTIs harder to treat in the future.

This kind of study is a 'Phase III' trial, which means it's a key step in checking if a treatment is safe and works well. The information gathered from this study will help doctors understand the best way to use antibiotics to treat children with fever-causing UTIs, aiming to get them better quickly and keep the infection from coming back.

Key takeaways

This study is examining an antibiotic called Augmentin for children's UTIs with fever.
It aims to see how well the medicine prevents the infection from returning.
Children of all ages, boys and girls, can be included.
Participation involves taking liquid medicine and attending follow-up appointments.
The study helps find the best way to treat these infections in children.

Who may be eligible?

Children of any age can be considered for this study, whether they are very young babies or older children. Both boys and girls can take part.

The main thing is that a child must have a urinary tract infection that is causing a fever. The doctors involved in the study will confirm if your child's specific condition matches what they are looking for.

There will be other detailed medical checks to make sure your child can safely take part in the study. These checks will be explained by the study team.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Does your child have a urinary tract infection (UTI)?
Is your child's UTI causing a fever?
Is your child able to take liquid medicine?
Are you able to attend regular follow-up appointments?
Are you interested in learning more about a new treatment approach for UTIs?

Answer every question to see your result.

What does participation involve?

If your child takes part in this study, they will receive the study medicine, Augmentin, as a liquid. The exact dose and how long they take it will be decided by the study doctors. You will be given clear instructions on how to give your child the medicine.

Throughout the study, your child will have regular check-ups with the study team. This will involve physical examinations and giving urine samples to see how well the treatment is working and if the infection has cleared. These follow-up visits are important to make sure your child is getting better and to check for any signs of the infection coming back.

The study will follow your child for at least 30 days after they finish their antibiotic medicine to see if the infection reappears. The study team will explain the full schedule of visits and tests, and the total duration of your child's involvement.

Potential risks and benefits

Taking part in this study might offer your child a carefully monitored treatment for their UTI. While the study medicine, Augmentin, is a commonly used antibiotic, like all medicines, it can have side effects. These are usually mild, such as tummy upset or rash, but the study team will monitor your child closely for any reactions. There's also the chance that the treatment might not work as hoped. You have the right to withdraw your child from the study at any time, for any reason, without it affecting your child's medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

—
Unverified
Italy

Common questions

What is a 'febrile' UTI?

A febrile UTI is a urinary tract infection that causes a fever, meaning your child's body temperature is higher than normal.

What is Augmentin?

Augmentin is a common antibiotic medicine used to treat various bacterial infections, including UTIs. In this study, it's given as a fruit-flavoured liquid.

Will my child definitely get Augmentin?

The study involves different groups, and the study doctors will explain which treatment path your child would be on. This is done to fairly compare treatments.

How often will my child need to visit the hospital?

Your child will have visits for monitoring and tests during the treatment and for at least 30 days afterwards. The study team will give you a full schedule.

What happens if the infection comes back?

The study team will closely monitor for the infection returning. If it does, your child will receive appropriate medical care, and this will be recorded for the study.