NCT03270540

Brief 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. 1.in the first day of treatment,
  2. 2.two weeks after treatment initiation,
  3. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
65

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 13, 2017

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

August 29, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 1, 2017

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 18, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 18, 2018

Completed
Last Updated

November 26, 2018

Status Verified

November 1, 2018

Enrollment Period

1.7 years

First QC Date

August 29, 2017

Last Update Submit

November 22, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • USG abnormality persistence

    significant abnormalities within kidney size or calices/pelvis/ureter dimensions, reproducible in subsequent USG examinations

    4 weeks

Eligibility Criteria

AgeUp to 3 Years
Sexall
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

children with UTI treated in Medical University of Warsaw Children's Hospital

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of Warsaw Children's Hospital

Warsaw, 02091, Poland

Location

Related Links

MeSH Terms

Conditions

Urinary Tract Infections

Condition Hierarchy (Ancestors)

InfectionsUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

August 29, 2017

First Posted

September 1, 2017

Study Start

March 13, 2017

Primary Completion

November 18, 2018

Study Completion

November 18, 2018

Last Updated

November 26, 2018

Record last verified: 2018-11

Locations