Short Therapy for Febrile UTI in Childhood

  • End date
    Dec 30, 2023
  • participants needed
  • sponsor
    IRCCS Burlo Garofolo
Updated on 17 December 2021
antibiotic therapy
clavulanic acid
urine culture
urinary catheterization
leukocyte esterase


Febrile urinary tract infections (UTIs) are common in children, but there is no consensus concerning the duration of the antibiotic treatment. Current recommendations include the use of an oral antibiotic, chosen between amoxicillin and clavulanic acid or a third-generation cephalosporin (ceftibuten), for a minimum of seven to a maximum of 14 days. In an antibiotic overuse-sparing model, proper evaluation of a shorter therapy in the treatment of febrile UTI in childhood is lacking.

The objective of this randomized controlled trial is to assess the non inferiority of a five days oral course of amoxicillin and clavulanic acid vs the standard 10-day regimen in the treatment of febrile UTIs in children.

The trial results might provide evidence of the non-inferiority of a short duration of the antibiotic course for the treatment of febrile UTI in childhood, contributing to a reduction in the over-use of antibiotics and consequently limiting the emergence of antibiotic resistance.

Condition Urinary Tract Infections
Treatment Amoxicillin and Clavulanic Acid in Oral Dose Form
Clinical Study IdentifierNCT04400110
SponsorIRCCS Burlo Garofolo
Last Modified on17 December 2021


Yes No Not Sure

Inclusion Criteria

Age from 3 months to 5 years
Clinical diagnosis of febrile UTI, defined by fever ≥38°C and positive result of urinalysis (nitrite and/or leukocyte esterase positivity) in two consecutive urine samples collected by bladder catheterization or clean catch (19). The diagnosis of UTI will be then confirmed by positive urine culture for a single type of bacterium with a charge> 105 CFU /ml as per the Recommendations of the Italian Society of Pediatric Nephrology (SINePe) (19)

Exclusion Criteria

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