<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/NCT03780140</url>
  </required_header>
  <id_info>
    <org_study_id>S-649266-EA</org_study_id>
    <nct_id>NCT03780140</nct_id>
  </id_info>
  <brief_title>Expanded Access to Cefiderocol for the Intravenous Treatment of Severe Gram Negative Bacterial Infections</brief_title>
  <official_title>Expanded Access to Cefiderocol for the Intravenous Treatment of Severe Gram Negative Bacterial Infections</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shionogi</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Shionogi Inc.</source>
  <brief_summary>
    <textblock>
      Expanded access may be provided for cefiderocol for qualified patients who have limited&#xD;
      treatment options and are not eligible for a clinical trial.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Approved for marketing</overall_status>
  <study_type>Expanded Access</study_type>
  <expanded_access_info>
    <expanded_access_type_individual>Yes</expanded_access_type_individual>
    <expanded_access_type_intermediate>Yes</expanded_access_type_intermediate>
  </expanded_access_info>
  <condition>Bacterial Infections</condition>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cefiderocol</intervention_name>
    <description>Cefiderocol for intravenous infusion</description>
    <other_name>S-649266</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Hospitalized patients with serious Gram-negative bacterial infections and who have limited&#xD;
        treatment options and are not eligible for a clinical trial.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Shionogi Clinical Trials Administrator Clinical Support Help Line</last_name>
    <role>Study Director</role>
    <affiliation>Shionogi</affiliation>
  </overall_official>
  <link>
    <url>https://www.shionogi.com/research/compassionate-use/</url>
    <description>Shionogi Compassionate Use</description>
  </link>
  <verification_date>February 2020</verification_date>
  <study_first_submitted>December 17, 2018</study_first_submitted>
  <study_first_submitted_qc>December 18, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 19, 2018</study_first_posted>
  <last_update_submitted>February 25, 2020</last_update_submitted>
  <last_update_submitted_qc>February 25, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">February 28, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>S-649266</keyword>
  <keyword>cefiderocol</keyword>
  <keyword>Gram-negative</keyword>
  <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>Bacterial Infections</mesh_term>
    <mesh_term>Gram-Negative Bacterial Infections</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/NCT03780140
org study id: S-649266-EA
nct id: NCT03780140
lead sponsor: 
Expanded access may be provided for cefiderocol for qualified patients who have limited
      treatment options and are not eligible for a clinical trial.
expanded access type individual: Yes
expanded access type intermediate: Yes
intervention type: Drug
intervention name: Cefiderocol
description: Cefiderocol for intravenous infusion
other name: S-649266
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
last name: Shionogi Clinical Trials Administrator Clinical Support Help Line
role: Study Director
affiliation: Shionogi
url: https://www.shionogi.com/research/compassionate-use/
description: Shionogi Compassionate Use
responsible party type: Sponsor
mesh term: Infections
mesh term: Communicable Diseases
mesh term: Bacterial Infections
mesh term: Gram-Negative Bacterial Infections