Short Therapy for Febrile UTI in Childhood

STATUS

Recruiting
participants needed

520
sponsor

IRCCS Burlo Garofolo

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Updated on 19 February 2024

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antibiotic

antibiotics

antibiotic therapy

fever

urine culture

urinary catheterization

nitrite

leukocyte esterase

clavulanic acid

urinary tract infection

cephalosporins

pediatric

acid vs

Summary

Show definitions

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.

Details

Condition	Urinary tract infection
Age	1years - 5years
Treatment	Amoxicillin and Clavulanic Acid in Oral Dose Form
Clinical Study Identifier	NCT04400110
Sponsor	IRCCS Burlo Garofolo
Last Modified on	19 February 2024

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Eligibility		Yes	No	Not Sure
Inclusion Criteria
	Age from 3 months to 5 years
	Clinical diagnosis of febrile UTI, defined by fever 38C 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
	Immunodeficiency
	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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Short Therapy for Febrile UTI in Childhood