<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03270540</url>
  </required_header>
  <id_info>
    <org_study_id>WarsawMU2W9</org_study_id>
    <nct_id>NCT03270540</nct_id>
  </id_info>
  <brief_title>Abdominal Ultrasonography in Urinary Tract Infection - When and Why?</brief_title>
  <official_title>Abdominal Ultrasonography in Urinary Tract Infection - When and Why?</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medical University of Warsaw</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medical University of Warsaw</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Urinary tract infection (UTI) in a child may be the first symptom of congenital anomaly of&#xD;
      the kidneys and the urinary tract (CAKUT). Thus, imaging diagnostics are warranted in&#xD;
      children with first episode of UTI.&#xD;
&#xD;
      Abdominal ultrasonography (USG) is the first line imaging modality in evaluating children&#xD;
      with UTI. Abnormalities suggesting CAKUT found on USG are an indication for further, more&#xD;
      invasive tests. The timing of USG in UTI depends on the clinical situation. It always should&#xD;
      be performed urgently when serious acute complications of UTI are suspected. However,&#xD;
      appropriate timing of USG in children responding well to therapy, is a matter of debate.&#xD;
      According to animal studies, E. coli produces toxin which dilates the urinary tract. This may&#xD;
      result in misleading picture on USG in acute phase of infection. Guidelines on UTI management&#xD;
      in children differ in respect to recommended USG timing.&#xD;
&#xD;
      The purpose of the study is to investigate how UTI does affect USG results in children and&#xD;
      when its effect subsides.&#xD;
&#xD;
      Methods 150 children up to 3 years of age, with the first episode of UTI, will be included in&#xD;
      our study. Three USG examinations will be performed by single radiologist in every child:&#xD;
&#xD;
        1. in the first day of treatment,&#xD;
&#xD;
        2. two weeks after treatment initiation,&#xD;
&#xD;
        3. four weeks after treatment initiation. Age, gender, etiologic factor, C-reactive protein&#xD;
           concentration and white blood cells count will be included in statistical analysis.&#xD;
&#xD;
      The study is aimed to help clinicians interpret USG findings during UTI and make reasonable&#xD;
      plans for further imaging diagnostics in children with UTI.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 13, 2017</start_date>
  <completion_date type="Actual">November 18, 2018</completion_date>
  <primary_completion_date type="Actual">November 18, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>USG abnormality persistence</measure>
    <time_frame>4 weeks</time_frame>
    <description>significant abnormalities within kidney size or calices/pelvis/ureter dimensions, reproducible in subsequent USG examinations</description>
  </primary_outcome>
  <enrollment type="Actual">65</enrollment>
  <condition>Urinary Tract Infections</condition>
  <condition>UTI</condition>
  <eligibility>
    <study_pop>
      <textblock>
        children with UTI treated in Medical University of Warsaw Children's Hospital&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        - laboratory diagnosis of UTI in a child (positive leucocyturia and significant&#xD;
        bacteriuria)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  known previous UTIs&#xD;
&#xD;
          -  known congenital abnormality of the kidney and the urinary tract (CAKUT)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>3 Years</maximum_age>
  </eligibility>
  <location>
    <facility>
      <name>Medical University of Warsaw Children's Hospital</name>
      <address>
        <city>Warsaw</city>
        <zip>02091</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Poland</country>
  </location_countries>
  <link>
    <url>https://www.nice.org.uk/guidance/qs36</url>
    <description>National Institute for Health and Care Excellence. Urinary tract infections in children and young people 2013 July</description>
  </link>
  <link>
    <url>http://uroweb.org/guideline/paediatric-urology/#3</url>
    <description>European Association of Urology; European Society for Pediatric Urology Urinary tract infections in children: (EAU/ESPU) guidelines.</description>
  </link>
  <link>
    <url>http://www.cps.ca/en/documents/position/urinary-tract-infections-in-children</url>
    <description>Canadian Paediatric Society, Urinary tract infection in infants and children: Diagnosis and management</description>
  </link>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>August 29, 2017</study_first_submitted>
  <study_first_submitted_qc>August 29, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 1, 2017</study_first_posted>
  <last_update_submitted>November 22, 2018</last_update_submitted>
  <last_update_submitted_qc>November 22, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 26, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Medical University of Warsaw</investigator_affiliation>
    <investigator_full_name>Magdalena Okarska-Napierała</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infections</mesh_term>
    <mesh_term>Communicable Diseases</mesh_term>
    <mesh_term>Urinary Tract Infections</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03270540
org study id: WarsawMU2W9
nct id: NCT03270540
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
observational model: Case-Only
time perspective: Prospective
measure: USG abnormality persistence
time frame: 4 weeks
description: significant abnormalities within kidney size or calices/pelvis/ureter dimensions, reproducible in subsequent USG examinations
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: 3 Years
facility: 
country: Poland
url: https://www.nice.org.uk/guidance/qs36
description: National Institute for Health and Care Excellence. Urinary tract infections in children and young people 2013 July
url: http://uroweb.org/guideline/paediatric-urology/#3
description: European Association of Urology; European Society for Pediatric Urology Urinary tract infections in children: (EAU/ESPU) guidelines.
url: http://www.cps.ca/en/documents/position/urinary-tract-infections-in-children
description: Canadian Paediatric Society, Urinary tract infection in infants and children: Diagnosis and management
responsible party type: Principal Investigator
investigator affiliation: Medical University of Warsaw
investigator full name: Magdalena Okarska-Napierała
investigator title: MD
mesh term: Infections
mesh term: Communicable Diseases
mesh term: Urinary Tract Infections
sharing ipd: Undecided