Skip to content

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

Status
Not yet recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2025-520622-38-00
Enrollment
520
Registered
2026-02-12
Start date
Unknown
Completion date
Unknown
Last updated
2026-02-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Urinary Tract Infections

Brief summary

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.

Detailed description

1. Short-term clinical efficacy between the two groups will be evaluated by clinical assessment and urinalysis during the follow-up., 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)

Interventions

DRUGAugmentin Fruit
DRUG400 mg/57 mg/5 ml suukaudse suspensiooni pulber

Sponsors

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

Eligibility

Sex/Gender
All
Age
0 Years to 17 Years

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
1. Short-term clinical efficacy between the two groups will be evaluated by clinical assessment and urinalysis during the follow-up., 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)

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 13, 2026