Clinical trial NCT04400110: Short Therapy for Febrile UTI in Childhood
Official title: Shortened Antibiotic Therapy for Febrile Urinary Tract Infection (UTI) in Childhood: a Multicenter Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Urinary Tract Infections
Keywords: short antibiotic therapy
urinary tract infection
children
Lead sponsor: IRCCS Burlo Garofolo
Sponsor class: OTHER
First posted: 2020-05-22
Enrollment: 154
Sex: ALL
Minimum age (years): 3
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

1. Age from 3 months to 5 years;
2. 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:

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. 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
10. Poor compliance
11. History of jaundice or liver failure positive

Primary outcomes:
measure: Rate of infection recurrence
timeFrame: within 30 days after the end of the intervention
Secondary outcomes:
measure: Rate of complete resolution of signs and symptoms
timeFrame: within 30 days after the end of the intervention
measure: Rate of antibiotic-resistant or of opportunistic strains in relapses
timeFrame: within 30 days after the end of the intervention
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: Policlinico S.Orsola-Malpighi
state: Emilia Romagna
city: Ravenna
country: Italy
facility: Santa Maria delle Croci Hospital
state: Emilia Romagna
city: Monfalcone
country: Italy
facility: Ospedale San Polo
state: Friuli Venezia Giulia
city: Pordenone
country: Italy
facility: Pediatric Department, Santa Maria degli Angeli Hospital
state: Friuli Venezia Giulia
city: Trieste
country: Italy
facility: Institute for Maternal and Child Health IRCCS Burlo Garofolo
state: Friuli Venezia Giulia
city: Udine
country: Italy
facility: ASUIUD Azienda sanitaria universitaria integrata di Udine
state: Friuli Venezia Giulia
city: Roma
country: Italy
facility: Fondazione Policlinico Agostino Gemelli - IRCCS City Rome
state: Lazio
city: Milano
country: Italy
facility: Fondazione IRCSS Ca Granda, Policlinico di Milano
state: Lombardia
city: Ancona
country: Italy
facility: Ospedali Riuniti di Ancona - Ospedale Salesi
state: Marche
city: Messina
country: Italy
facility: A.O.U.G. Martino
state: Sicilia
city: Belluno
country: Italy
facility: San Martino Hospital
state: Veneto
city: Padua
country: Italy
facility: Department of Woman and Child Health, University of Padua City
state: Veneto
city: Treviso
country: Italy
facility: UOC Pediatria Ospedale Ca' Foncello
state: Veneto
Study officials:
affiliation: Institute for maternal and child health Burlo Garofolo
name: Egidio Barbi, MD Prof
role: STUDY_CHAIR
affiliation: Institute for maternal and child health Burlo Garofolo
name: Marco Pennesi, MD
role: PRINCIPAL_INVESTIGATOR
References: