Abdominal Ultrasonography in Urinary Tract Infection - When and Why?

Urinary Tract Infections Clinical Trial

Official title:

Abdominal Ultrasonography in Urinary Tract Infection - When and Why?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03270540
• Other study ID #: WarsawMU2W9
• Status: Completed
• Start date: March 13, 2017
• Est. completion date: November 18, 2018

Study information

• Verified date: November 2018
• Source: Medical University of Warsaw
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Urinary tract infection (UTI) in a child may be the first symptom of congenital anomaly of the kidneys and the urinary tract (CAKUT). Thus, imaging diagnostics are warranted in children with first episode of UTI.

Abdominal ultrasonography (USG) is the first line imaging modality in evaluating children with UTI. Abnormalities suggesting CAKUT found on USG are an indication for further, more invasive tests. The timing of USG in UTI depends on the clinical situation. It always should be performed urgently when serious acute complications of UTI are suspected. However, appropriate timing of USG in children responding well to therapy, is a matter of debate. According to animal studies, E. coli produces toxin which dilates the urinary tract. This may result in misleading picture on USG in acute phase of infection. Guidelines on UTI management in children differ in respect to recommended USG timing.

The purpose of the study is to investigate how UTI does affect USG results in children and when its effect subsides.

Methods 150 children up to 3 years of age, with the first episode of UTI, will be included in our study. Three USG examinations will be performed by single radiologist in every child:

1. in the first day of treatment,

2. two weeks after treatment initiation,

3. four weeks after treatment initiation. Age, gender, etiologic factor, C-reactive protein concentration and white blood cells count will be included in statistical analysis.

The study is aimed to help clinicians interpret USG findings during UTI and make reasonable plans for further imaging diagnostics in children with UTI.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: November 18, 2018
• Est. primary completion date: November 18, 2018
• Gender: All
• Age group: N/A to 3 Years

Eligibility

Inclusion Criteria:

• laboratory diagnosis of UTI in a child (positive leucocyturia and significant bacteriuria)

Exclusion Criteria:

• known previous UTIs

• known congenital abnormality of the kidney and the urinary tract (CAKUT)

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Urinary Tract Infections
• UTI

Locations

Country	Name	City	State
Poland	Medical University of Warsaw Children's Hospital	Warsaw

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Warsaw

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	USG abnormality persistence	significant abnormalities within kidney size or calices/pelvis/ureter dimensions, reproducible in subsequent USG examinations	4 weeks

External Links

•   American Academy of Pediatrics: Clinical Practice Guideline for the Diagnosis and Management of the Initial UTI in Febrile Infants and Children 2 to 24 Months
•   Canadian Paediatric Society, Urinary tract infection in infants and children: Diagnosis and management
•   European Association of Urology; European Society for Pediatric Urology Urinary tract infections in children: (EAU/ESPU) guidelines.
•   National Institute for Health and Care Excellence. Urinary tract infections in children and young people 2013 July
•   Polish Society of Pediatric Nephrology, Guidelines in UTI