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Personalized antibiotic TREATment for febrile Urinary Tract Infections in children (TREAT-UTI study): multicenter randomized controlled trial
EU CTIS ID: 2025-520622-38-00
What this study is testing
The primary objective is to determine if antibiotic therapy with amoxicillin and clavulanic acid taken for a period of 24 hours after the resolution of fever is non-inferior to the standard 10-day regimen in terms of rate of infection recurrence, defined as the reappearance of signs and symptoms of febrile UTI within 30 days after the end of antibiotic therapy
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Age from 3 months to 3 years
- Clinical diagnosis of febrile UTI, defined by fever ≥38°C and positive result of urinalysis (nitrite and/or leukocyte esterase positivity) on urine samples collected according to Italian Society of Pediatric Nephrology (SINePe) guidelines. The diagnosis of UTI will be then confirmed by positive urine culture for a single type of bacterium with a charge >105 CFU/ml (>104 CFU/ml for urine samples collected by bladder catheterization) as per the Recommendations of the SINePe;
- Informed consent signed by parents
You likely can't join if
- 1. "Complicated" febrile UTI (septic appearance, repeated vomiting impeding oral administration of the antibiotic, severe-moderate dehydration with the need for intravenous antibiotic therapy);
- 10. Poor compliance;
- 11. History of jaundice or liver failure.
- 2. Presence of an inserted urinary catheter;
- 3. Immunodeficiency;
- 4. Hypersensitivity to the active substance or other beta-lactam antibiotics;
See the full eligibility criteria
- Age from 3 months to 3 years
- Clinical diagnosis of febrile UTI, defined by fever ≥38°C and positive result of urinalysis (nitrite and/or leukocyte esterase positivity) on urine samples collected according to Italian Society of Pediatric Nephrology (SINePe) guidelines. The diagnosis of UTI will be then confirmed by positive urine culture for a single type of bacterium with a charge >105 CFU/ml (>104 CFU/ml for urine samples collected by bladder catheterization) as per the Recommendations of the SINePe;
- Informed consent signed by parents
- 1. "Complicated" febrile UTI (septic appearance, repeated vomiting impeding oral administration of the antibiotic, severe-moderate dehydration with the need for intravenous antibiotic therapy);
- 10. Poor compliance;
- 11. History of jaundice or liver failure.
- 2. Presence of an inserted urinary catheter;
- 3. Immunodeficiency;
- 4. Hypersensitivity to the active substance or other beta-lactam antibiotics;
- 5. Any antibiotic treatment received in the previous 15 days;
- 6. Presence of another poorly controlled chronic medical condition (diabetes, inflammatory bowel disease, etc.);
- 7. Presence of neurological bladder;
- 8. Presence of phenylketonuria or glucose-galactose malabsorption;
- 9. Intestinal malabsorption;
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.