<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/NCT04479982</url>
  </required_header>
  <id_info>
    <org_study_id>Microbial infection with covid</org_study_id>
    <nct_id>NCT04479982</nct_id>
  </id_info>
  <brief_title>Microbial Infection and AMR in Hospitalized Patients With Covid 19</brief_title>
  <official_title>Microbial Infections and Antimicrobial Resistance (AMR) Patterns Associated With Hospitalized Patients With 2019 Novel Coronavirus Disease (COVID 19)</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>
      To detect microbial infection and AMR associated with COVID 19 infection.&#xD;
&#xD;
      To correlate risk factors of COVID 19 patients with microbial infections and their effects on&#xD;
      disease.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The most common type of infection among ICU patients was bacterial or fungal pneumonia;&#xD;
      bloodstream and urinary tract infections were also noted. Organisms cultured from patients&#xD;
      included pandrug-resistant Acinetobacter baumannii, Klebsiella pneumoniae&#xD;
      carbapenemase-producing K. pneumoniae, extended-spectrum β-lactamase (ESBL)- producing K.&#xD;
      pneumoniae, ESBL-producing Pseudomonas aeruginosa, Enterobacter cloacae, Serratia marcescens,&#xD;
      Aspergillus fumigatus, Aspergillus flavus, Candida albicans, and Candida glabrata .&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Anticipated">September 24, 2020</start_date>
  <completion_date type="Anticipated">December 31, 2020</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Microbial infections and antimicrobial resistance (AMR) patterns associated with hospitalized patients with 2019 novel coronavirus disease (COVID 19)</measure>
    <time_frame>baseline</time_frame>
    <description>The correlation between microbial infection and COVID 19 infection and their effect on prognosis and disease outcome.</description>
  </primary_outcome>
  <enrollment type="Anticipated">70</enrollment>
  <condition>Covid19</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Hospitalized patients with covid 19&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with Covid infection&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients without covid 19&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Alshymaa Ali, PHD</last_name>
    <phone>01090581638</phone>
    <email>shimaafahim25@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Assiut hopital</name>
      <address>
        <city>Assiut</city>
        <zip>6001</zip>
        <country>Egypt</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>shimaa faheem, master</last_name>
    </contact>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>September 2020</verification_date>
  <study_first_submitted>July 17, 2020</study_first_submitted>
  <study_first_submitted_qc>July 20, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 21, 2020</study_first_posted>
  <last_update_submitted>September 20, 2020</last_update_submitted>
  <last_update_submitted_qc>September 20, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">September 22, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>ALShymaa faheem solyman ali</investigator_full_name>
    <investigator_title>assistant lecturer</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
  </condition_browse>
  <!-- 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/NCT04479982
org study id: Microbial infection with covid
nct id: NCT04479982
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
To detect microbial infection and AMR associated with COVID 19 infection.

      To correlate risk factors of COVID 19 patients with microbial infections and their effects on
      disease.
The most common type of infection among ICU patients was bacterial or fungal pneumonia;
      bloodstream and urinary tract infections were also noted. Organisms cultured from patients
      included pandrug-resistant Acinetobacter baumannii, Klebsiella pneumoniae
      carbapenemase-producing K. pneumoniae, extended-spectrum β-lactamase (ESBL)- producing K.
      pneumoniae, ESBL-producing Pseudomonas aeruginosa, Enterobacter cloacae, Serratia marcescens,
      Aspergillus fumigatus, Aspergillus flavus, Candida albicans, and Candida glabrata .
observational model: Other
time perspective: Prospective
measure: Microbial infections and antimicrobial resistance (AMR) patterns associated with hospitalized patients with 2019 novel coronavirus disease (COVID 19)
time frame: baseline
description: The correlation between microbial infection and COVID 19 infection and their effect on prognosis and disease outcome.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Alshymaa Ali, PHD
phone: 01090581638
email: shimaafahim25@gmail.com
facility: 
status: Recruiting
contact: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: ALShymaa faheem solyman ali
investigator title: assistant lecturer
mesh term: COVID-19