<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/NCT04431440</url>
  </required_header>
  <id_info>
    <org_study_id>XXXXX</org_study_id>
    <nct_id>NCT04431440</nct_id>
  </id_info>
  <brief_title>Silver Nanoparticles in Multidrug Resistant Bacteria</brief_title>
  <official_title>Bactericidal Effect of Silver Nanoparticles on Methecillin and Vancomycin Resistant Staphylococcus. Aureus (MRSA) Isolated From Critically Ill Patients</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>
      Recently, silver nanoparticles (AgNPs) have been widely used in various applications as&#xD;
      antimicrobial agents, anticancer, diagnostics, biomarkers, cell labels, and drug delivery&#xD;
      systems for the treatment of various diseases. The present study investigated the&#xD;
      bactericidal effect of AgNPs against Methecillin Resistant Staph. aureus (MRSA) and&#xD;
      Vancomycin resistant Staph aureus (VRSA)&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 1, 2020</start_date>
  <completion_date type="Actual">October 13, 2020</completion_date>
  <primary_completion_date type="Actual">October 5, 2020</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>bactericidal effect of silver nanoparticles on multidrug resistant bacteria</measure>
    <time_frame>24 hours</time_frame>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">150</enrollment>
  <condition>Multidrug Resistent Bacteria</condition>
  <arm_group>
    <arm_group_label>Methicillin resistant staphylococcus aureus</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>vancomycin resistent staphylococcus aureus</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>silver nanoparticles</intervention_name>
    <description>effect silver nanoparticles will be examined on multidrug resistant bacteria</description>
    <arm_group_label>Methicillin resistant staphylococcus aureus</arm_group_label>
    <arm_group_label>vancomycin resistent staphylococcus aureus</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        critically ill patients&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Intensive care patients&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  none&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <location>
    <facility>
      <name>Assiut university</name>
      <address>
        <city>Assiut</city>
        <zip>71111</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>November 2020</verification_date>
  <study_first_submitted>June 11, 2020</study_first_submitted>
  <study_first_submitted_qc>June 11, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 16, 2020</study_first_posted>
  <last_update_submitted>November 4, 2020</last_update_submitted>
  <last_update_submitted_qc>November 4, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 5, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>Rasha Hamed</investigator_full_name>
    <investigator_title>lecturer of anaesthesia</investigator_title>
  </responsible_party>
  <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/NCT04431440
org study id: XXXXX
nct id: NCT04431440
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Recently, silver nanoparticles (AgNPs) have been widely used in various applications as
      antimicrobial agents, anticancer, diagnostics, biomarkers, cell labels, and drug delivery
      systems for the treatment of various diseases. The present study investigated the
      bactericidal effect of AgNPs against Methecillin Resistant Staph. aureus (MRSA) and
      Vancomycin resistant Staph aureus (VRSA)
observational model: Case-Only
time perspective: Prospective
measure: bactericidal effect of silver nanoparticles on multidrug resistant bacteria
time frame: 24 hours
arm group label: Methicillin resistant staphylococcus aureus
arm group label: vancomycin resistent staphylococcus aureus
intervention type: Other
intervention name: silver nanoparticles
description: effect silver nanoparticles will be examined on multidrug resistant bacteria
arm group label: Methicillin resistant staphylococcus aureus
arm group label: vancomycin resistent staphylococcus aureus
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: Rasha Hamed
investigator title: lecturer of anaesthesia
sharing ipd: Undecided