Ultrasonography in Children With First Febrile Urinary Tract Infection

NCT ID: NCT05814250

Last Updated: 2024-06-12

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 20 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-06-13
• Study Completion Date: 2028-03-31

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

Conditions

Urinary Tract Infections

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: CROSS_SECTIONAL

Eligibility Criteria

Inclusion Criteria

• Patient with first episode of fUTI that subsequently do KUS.

Exclusion Criteria

• patients with previous episodes of UTIs
• patients on antibiotic prophylaxis
• previous finding of malformative uropathies or cystic disease
• prenatal diagnosis of CAKUT with the following parameters: Presence of oligohydramnios, alterations in renal number, location and echo structure, bladder alteration, dilations of the renal pelvis and ureters

• Minimum Eligible Age: 2 Months
• Maximum Eligible Age: 3 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

IRCCS Burlo Garofolo

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marco Pennesi, MD

Role: STUDY_DIRECTOR

IRCCS materno infantile Burlo Garofolo

Locations

AOU Meyer IRCCS

Florence, , Italy

Site Status: RECRUITING

IRCCS Policlinico Cà Granda

Milan, , Italy

Site Status: RECRUITING

IRCCS materno infantile Burlo Garofolo

Trieste, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Marco Pennesi, MD

Role: CONTACT

marco.pennesi@burlo.trieste.it

+39 040.3785.263

Facility Contacts

Luigi Cirillo, MD

Role: primary

luigi.cirillo@meyer.it,

Francesca Beccherucci, MD

Role: backup

francesca.becherucci@gmail.com,

Giovanni Montini, Md

Role: primary

giovanni.montini@unimi.it

Marco Pennesi, MD

Role: primary

marco.pennesi@burlo.trieste.it

+39 040.3785.263

Other Identifiers

RC 01/22

Identifier Type: -

Identifier Source: org_study_id