<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/NCT03281863</url>
  </required_header>
  <id_info>
    <org_study_id>AssiutU71516</org_study_id>
    <nct_id>NCT03281863</nct_id>
  </id_info>
  <brief_title>Clinical Audit on the Managment in Assiut University Children Hospital</brief_title>
  <official_title>Clinical Audit on the Managment of Rheumatic Fever in Assiut University Children Hospital</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assiut University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assiut University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      clinical audit on the Managment of rheumatic fever in assiut university children hospital.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Acute rheumatic fever,an auto immune response to Group A streptococcus infection of the upper&#xD;
      respiratory tract,may result in carditis.when the inflammation leads to permenant damage of&#xD;
      the valves the individual has rheumatic heart disease.&#xD;
&#xD;
      Recurrences of rheumatic fever are likely in the absence of preventive measures and may cause&#xD;
      further cardiac valve and muscle damage,leading to heart failure,stroke and premature&#xD;
      death.bacterial endocarditis is also a complication.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 1, 2018</start_date>
  <completion_date type="Actual">March 24, 2020</completion_date>
  <primary_completion_date type="Actual">March 24, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>laboratory investigations (ASOt , ESR . CRP)</measure>
    <time_frame>One year from October 2017 to september 2018</time_frame>
    <description>laboratory investigations that measure the inflammation process will be used and the target that the ASOt not increase 1/400</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>clinical measures</measure>
    <time_frame>One year from October 2017 to september 2018</time_frame>
    <description>improvement of arthritis if found</description>
  </secondary_outcome>
  <enrollment type="Actual">100</enrollment>
  <condition>Rheumatic Fever</condition>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>C reactive protein, anti streptolysin o antibody test ,erythrocyte sedimentation rate</intervention_name>
    <description>Throat culture to detect the causative organism</description>
    <other_name>Throat culture</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Clinical audit on the managment of rheumatic fever in assiut university children hospital&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients with confirmed diagnosis of rheumatic fever based on laboratory&#xD;
             investigations.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  No&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>5 Years</minimum_age>
    <maximum_age>15 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Egypt</name>
      <address>
        <city>Assiut</city>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>March 2021</verification_date>
  <study_first_submitted>August 29, 2017</study_first_submitted>
  <study_first_submitted_qc>September 11, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 13, 2017</study_first_posted>
  <last_update_submitted>March 24, 2021</last_update_submitted>
  <last_update_submitted_qc>March 24, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 26, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>Patricia reda hanna</investigator_full_name>
    <investigator_title>Resident doctor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Rheumatic Fever</mesh_term>
    <mesh_term>Rheumatic Diseases</mesh_term>
    <mesh_term>Fever</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Antibodies</mesh_term>
    <mesh_term>Antistreptolysin</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT03281863
org study id: AssiutU71516
nct id: NCT03281863
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
clinical audit on the Managment of rheumatic fever in assiut university children hospital.
Acute rheumatic fever,an auto immune response to Group A streptococcus infection of the upper
      respiratory tract,may result in carditis.when the inflammation leads to permenant damage of
      the valves the individual has rheumatic heart disease.

      Recurrences of rheumatic fever are likely in the absence of preventive measures and may cause
      further cardiac valve and muscle damage,leading to heart failure,stroke and premature
      death.bacterial endocarditis is also a complication.
observational model: Cohort
time perspective: Prospective
measure: laboratory investigations (ASOt , ESR . CRP)
time frame: One year from October 2017 to september 2018
description: laboratory investigations that measure the inflammation process will be used and the target that the ASOt not increase 1/400
measure: clinical measures
time frame: One year from October 2017 to september 2018
description: improvement of arthritis if found
intervention type: Diagnostic Test
intervention name: C reactive protein, anti streptolysin o antibody test ,erythrocyte sedimentation rate
description: Throat culture to detect the causative organism
other name: Throat culture
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 5 Years
maximum age: 15 Years
healthy volunteers: No
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: Patricia reda hanna
investigator title: Resident doctor
mesh term: Rheumatic Fever
mesh term: Rheumatic Diseases
mesh term: Fever
mesh term: Antibodies
mesh term: Antistreptolysin
sharing ipd: No