Ultrasonography in Children With First Febrile Urinary Tract Infection

Urinary Tract Infections Clinical Trial

Official title:

Is Ultrasonography Mandatory in All Children at Their First Febrile Urinary Tract Infection?

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05814250
• Other study ID #: RC 01/22
• Status: Recruiting
• Start date: June 13, 2022
• Est. completion date: March 31, 2028

Study information

• Verified date: June 2024
• Source: IRCCS Burlo Garofolo
• Contact: Marco Pennesi, MD
• Phone: +39 040.3785.263
• Email: marco.pennesi[@]burlo.trieste.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: March 31, 2028
• Est. primary completion date: March 31, 2025
• Gender: All
• Age group: 2 Months to 3 Years

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Infections
• Urinary Tract Infections

Locations

Country	Name	City	State
Italy	AOU Meyer IRCCS	Firenze
Italy	IRCCS Policlinico Cà Granda	Milano
Italy	IRCCS materno infantile Burlo Garofolo	Trieste

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS Burlo Garofolo

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the diagnostic accuracy of the presence of an atypical germ combined with the possible recurrence of UTI in predicting the positivity of KUS in children aged between 2 months and 3 years with first episode of fUTI	Sensitivity, specificity positive and negative predictive values will be evaluated. Patient will be recruited prospectively. A first sample of urine culture can be collected from urine bag, and analyzed by urine dipstick. If urine dipstick tests positive such as positivity for leukocytes and/or nitrites, a second sample will be collected with sterile methods as clan catch or bladder catheterization. Urine culture will be performed in both urine samples. In case of a UTI a subsequent follow up is recommended with an abdominal ultrasound after one month. In case of a pathological ultrasound, the subsequent diagnostic follow up it is up to the clinician, with voiding cystography or scintigraphy. During the follow up period UTI relapses will be detected.	Follow up of 2 years or until the third year of age
Secondary	To evaluate the diagnostic accuracy of urinary culture carried out from urinary bag vs a second sample gathered from the same patient by clean catch or bladder catheterization (gold standard)	Sensitivity, specificity positive and negative predictive values will be evaluated	At the time of urine collection (baseline)
Secondary	To evaluate the concordance of the germs found in positive urinary culture carried out from urinary bag vs clean catch or bladder catheterization gathered from the same patient	The concordance of the germs found with the two different samples collections will be evaluated using the Cohen's kappa coefficient	At the time of urine collection (baseline)