Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Abdominal Ultrasonography in Urinary Tract Infection - When and Why?

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03270540
Recruitment Status : Completed
First Posted : September 1, 2017
Last Update Posted : November 26, 2018
Sponsor:
Information provided by (Responsible Party):
Magdalena Okarska-Napierała, Medical University of Warsaw

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. 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.


Condition or disease
Urinary Tract Infections UTI

Layout table for study information
Study Type : Observational
Actual Enrollment : 65 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Abdominal Ultrasonography in Urinary Tract Infection - When and Why?
Actual Study Start Date : March 13, 2017
Actual Primary Completion Date : November 18, 2018
Actual Study Completion Date : November 18, 2018

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. USG abnormality persistence [ Time Frame: 4 weeks ]
    significant abnormalities within kidney size or calices/pelvis/ureter dimensions, reproducible in subsequent USG examinations



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   up to 3 Years   (Child)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
children with UTI treated in Medical University of Warsaw Children's Hospital
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03270540


Locations
Layout table for location information
Poland
Medical University of Warsaw Children's Hospital
Warsaw, Poland, 02091
Sponsors and Collaborators
Medical University of Warsaw
Additional Information:
Layout table for additonal information
Responsible Party: Magdalena Okarska-Napierała, MD, Medical University of Warsaw
ClinicalTrials.gov Identifier: NCT03270540    
Other Study ID Numbers: WarsawMU2W9
First Posted: September 1, 2017    Key Record Dates
Last Update Posted: November 26, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Infection
Communicable Diseases
Urinary Tract Infections
Urologic Diseases