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Abdominal Ultrasonography in Urinary Tract Infection - When and Why?

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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

Tracking Information
First Submitted Date August 29, 2017
First Posted Date September 1, 2017
Last Update Posted Date November 26, 2018
Actual Study Start Date March 13, 2017
Actual Primary Completion Date November 18, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 29, 2017)
USG abnormality persistence [ Time Frame: 4 weeks ]
significant abnormalities within kidney size or calices/pelvis/ureter dimensions, reproducible in subsequent USG examinations
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Abdominal Ultrasonography in Urinary Tract Infection - When and Why?
Official Title Abdominal Ultrasonography in Urinary Tract Infection - When and Why?
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.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population children with UTI treated in Medical University of Warsaw Children's Hospital
Condition
  • Urinary Tract Infections
  • UTI
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: November 22, 2018)
65
Original Estimated Enrollment
 (submitted: August 29, 2017)
150
Actual Study Completion Date November 18, 2018
Actual Primary Completion Date November 18, 2018   (Final data collection date for primary outcome measure)
Eligibility 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)
Sex/Gender
Sexes Eligible for Study: All
Ages up to 3 Years   (Child)
Accepts Healthy Volunteers Not Provided
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Poland
Removed Location Countries  
 
Administrative Information
NCT Number NCT03270540
Other Study ID Numbers WarsawMU2W9
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Magdalena Okarska-Napierała, Medical University of Warsaw
Study Sponsor Medical University of Warsaw
Collaborators Not Provided
Investigators Not Provided
PRS Account Medical University of Warsaw
Verification Date November 2018