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

Overview

Sponsor-declared trial summary

Key facts

Sponsor

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

Participant type

Pediatric, Patients

Age range

0-17 years

Gender

Male and Female

Therapeutic area

Diseases [C] - Bacterial Infections and Mycoses [C01], Diseases [C] - Male Urogenital Diseases [C12], Diseases [C] - Female Urogenital Diseases and Pregnancy Complications [C13]

Decision date (initial)

2026-02-12

Transition trial

No

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

Yes

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Therapy, Others

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

Secondary objectives 2

1. To evaluate short-term clinical efficacy of personalized therapy, defined as the complete resolution of the signs and symptoms related to the infection at the end of the treatment, without the need for additional or alternative antibiotic therapy.
2. To evaluate the presence of antibiotic-resistant or opportunistic strains in relapses

Conditions and MedDRA coding

Urinary Tract Infections

Study design 1 period

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 3

1. Age from 3 months to 3 years
2. 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;
3. Informed consent signed by parents

Exclusion criteria 11

1. 1. "Complicated" febrile UTI (septic appearance, repeated vomiting impeding oral administration of the antibiotic, severe-moderate dehydration with the need for intravenous antibiotic therapy);
2. 2. Presence of an inserted urinary catheter;
3. 3. Immunodeficiency;
4. 4. Hypersensitivity to the active substance or other beta-lactam antibiotics;
5. 5. Any antibiotic treatment received in the previous 15 days;
6. 6. Presence of another poorly controlled chronic medical condition (diabetes, inflammatory bowel disease, etc.);
7. 7. Presence of neurological bladder;
8. 8. Presence of phenylketonuria or glucose-galactose malabsorption;
9. 9. Intestinal malabsorption;
10. 10. Poor compliance;
11. 11. History of jaundice or liver failure.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Rate of infection recurrence, defined as the reappearance of signs and symptoms of febrile UTI and positive urine culture within 30 days after the end of antibiotic therapy.

Secondary endpoints 2

1. 1. Short-term clinical efficacy between the two groups will be evaluated by clinical assessment and urinalysis during the follow-up.
2. 2. The rate of emergence of antibiotic-resistance or opportunistic strains, defined as the presence of positive urinalysis and positive urine culture for a single type of bacterium resistant to amoxicillin and clavulanic acid, after treatment in case of relapse. It will only be evaluated in suspected relapses by carrying out a urine test and urine culture. The bacterial growth will be considered significant if >105 CF/ml (>104 CFU/ml for urine samples collected by bladder catheterization)

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

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

Sponsor organisation

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

Address

Via Dell' Istria 65/1

City

Trieste

Postcode

34137

Country

Italy

Scientific contact point

Organisation

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

Contact name

Prof. E. Barbi

Public contact point

Organisation

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

Contact name

Dott.ssa A. Maestro

Locations

1 EU/EEA country · 20 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 17 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications