Ignite Creation Date:
2024-05-06 @ 6:52 PM
Last Modification Date:
2024-10-26 @ 2:56 PM
Study NCT ID:
NCT05814250
Status:
RECRUITING
Last Update Posted:
2024-06-12
First Post:
2023-03-28
Brief Title:
Ultrasonography in Children With First Febrile Urinary Tract Infection
Sponsor:
IRCCS Burlo Garofolo
Organization:
IRCCS Burlo Garofolo
Study Overview
Official Title:
Is Ultrasonography Mandatory in All Children at Their First Febrile Urinary Tract Infection
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
In recent decades different tests have been recommended by guidelines in the management of first febrile urinary tract infection fUTI in children including kidney ultrasound KUS cystography VCUG and renal scintigraphy in order to exclude underlying kidney anomalies The majority of guidelines continue to recommend a routine KUS for all children at the first fUTI On the other hand as this approach is not based on robust evidence other guidelines suggest that KUS should only be performed on selected patients according to specific risks Despite being a non-invasive and radiation-free method KUS tests negative in 83 of cases of fUTIs and possesses low specificity for low grade vesico-ureteral reflux VUR Since VUR is the most commonly associated renal malformation with UTI it is evident that all the guidelines focus on the research of VUR especially in times when antenatal ultrasound allows to screen for major congenital anomalies of kidney and urinary tract CAKUT However VUR-associated nephropathy appears to be related to primary dysplastic damage rather than to be secondary to the reflux itself and not preventable from antibiotic prophylaxis in terms of recurrence and of kidney scar To reduce the number of normal VCUGs performed recent evidence regarding VUR suggests that the presence of pathogens different from E coli and UTI recurrence may help to identify children who necessitate further investigations A preliminary retrospective monocentric study enrolling all patients aged 2 to 36 months diagnosed with first fUTI who subsequently underwent US evaluation of the kidneys and urinary tract found that atypical germ and recurrence of UTI exhibits a 85 sensitivity to detect pathological ultrasound The aim of this multicentric study is to prospectively evaluate the diagnostic accuracy of the presence of atypical germ combined with the recurrence of UTI in predicting the positivity of KUS in children aged 2 months to 3 years old with first episode of fUTI
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None