Status:
COMPLETED
Short Therapy for Febrile UTI in Childhood
Lead Sponsor:
IRCCS Burlo Garofolo
Conditions:
Urinary Tract Infections
Eligibility:
All Genders
3-5 years
Phase:
PHASE4
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 antibi...
Eligibility Criteria
Inclusion
- 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
- "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
Key Trial Info
Start Date :
June 8 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2022
Estimated Enrollment :
154 Patients enrolled
Trial Details
Trial ID
NCT04400110
Start Date
June 8 2020
End Date
December 31 2022
Last Update
March 29 2023
Active Locations (13)
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1
Policlinico S.Orsola-Malpighi
Bologna, Emilia-Romagna, Italy, 40138
2
Santa Maria delle Croci Hospital
Ravenna, Emilia-Romagna, Italy, 48121
3
Ospedale San Polo
Monfalcone, Friuli Venezia Giulia, Italy, 34074
4
Pediatric Department, Santa Maria degli Angeli Hospital
Pordenone, Friuli Venezia Giulia, Italy, 33170