<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/NCT03770533</url>
  </required_header>
  <id_info>
    <org_study_id>IDEAL pilot</org_study_id>
    <nct_id>NCT03770533</nct_id>
  </id_info>
  <brief_title>Identifying Patients With Suspicion of Infection in the ED Who Have Low Disease Severity Using MR-proADM - Pilot Study</brief_title>
  <acronym>IDEAL</acronym>
  <official_title>Identifying Patients With Suspicion of Infection in the ED Who Have Low Disease Severity Using Midregional Proadrenomedullin (MR-proADM) - Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Brahms AG</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Brahms AG</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>
      Emergency departments (ED) are becoming increasingly over-crowded, with patients facing&#xD;
      prolonged waiting times. Therefore, a safe and rapid assessment that identifies patients with&#xD;
      low severity that could be treated as outpatients is essential for improving the workflow&#xD;
      within the ED.&#xD;
&#xD;
      The rationale of this IDEAL study is to provide guidance to safely decrease the number of&#xD;
      hospital admissions through identification of low risk patients with the biomarker MR-proADM.&#xD;
      This will be tested in a pilot study first.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 14, 2018</start_date>
  <completion_date type="Actual">December 11, 2019</completion_date>
  <primary_completion_date type="Actual">December 11, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Rate of patients admitted to the hospital</measure>
    <time_frame>14 days</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>28 days all-cause hospital re-admission (corrected for mortality)</measure>
    <time_frame>28 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients re-presenting to the ED within 28 days</measure>
    <time_frame>28 days</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">200</enrollment>
  <condition>Patients Presenting With Suspicion of Infection to the ED</condition>
  <arm_group>
    <arm_group_label>MR-proADM guided</arm_group_label>
    <arm_group_type>Other</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard Care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>MR-proADM guided</intervention_name>
    <description>MR-proADM value together with routine clinical evaluation identifies patients with a low 14 day mortality risk who do not need to be hospitalized</description>
    <arm_group_label>MR-proADM guided</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Consecutive patients presenting to the ED with suspicion of infection&#xD;
&#xD;
          -  Age ≥18 years&#xD;
&#xD;
          -  Written Informed Consent obtained&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Recent major trauma or surgery&#xD;
&#xD;
          -  End stage renal failure requiring dialysis&#xD;
&#xD;
          -  Terminal disease and/or very severe medical co-morbidity where death has to be&#xD;
             expected in the next 6 months, e.g. due to malignancy, cardiac, renal or hepatic&#xD;
             failure&#xD;
&#xD;
          -  Patients those source of infection always requires hospital admission or never&#xD;
             requires hospital admission.&#xD;
&#xD;
          -  Patients who cannot be discharged for other than medical reasons&#xD;
&#xD;
          -  Patient participates in any other interventional clinical trial&#xD;
&#xD;
          -  Patients with active intravenous drug use&#xD;
&#xD;
          -  Pregnant or lactating women&#xD;
&#xD;
          -  Patients who are institutionalized by official or judicial order&#xD;
&#xD;
          -  Dependents of the sponsor, the CRO, the study site or the investigator&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Juan Gonzalez del Castillo</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospital Clinico San Carlos</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hospital Universitario Central de Asturias</name>
      <address>
        <city>Oviedo</city>
        <state>Asturias</state>
        <zip>33011</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario de Bellvitge</name>
      <address>
        <city>Barcelona</city>
        <zip>08907</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Clínico San Carlos</name>
      <address>
        <city>Madrid</city>
        <zip>28040</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Virgen Macarena</name>
      <address>
        <city>Sevilla</city>
        <zip>41009</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>December 2019</verification_date>
  <study_first_submitted>December 7, 2018</study_first_submitted>
  <study_first_submitted_qc>December 7, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 10, 2018</study_first_posted>
  <last_update_submitted>December 11, 2019</last_update_submitted>
  <last_update_submitted_qc>December 11, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">December 12, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </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>
  </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/NCT03770533
org study id: IDEAL pilot
nct id: NCT03770533
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Emergency departments (ED) are becoming increasingly over-crowded, with patients facing
      prolonged waiting times. Therefore, a safe and rapid assessment that identifies patients with
      low severity that could be treated as outpatients is essential for improving the workflow
      within the ED.

      The rationale of this IDEAL study is to provide guidance to safely decrease the number of
      hospital admissions through identification of low risk patients with the biomarker MR-proADM.
      This will be tested in a pilot study first.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: None (Open Label)
measure: Rate of patients admitted to the hospital
time frame: 14 days
measure: 28 days all-cause hospital re-admission (corrected for mortality)
time frame: 28 days
measure: Number of patients re-presenting to the ED within 28 days
time frame: 28 days
arm group label: MR-proADM guided
arm group type: Other
arm group label: Standard Care
arm group type: No Intervention
intervention type: Other
intervention name: MR-proADM guided
description: MR-proADM value together with routine clinical evaluation identifies patients with a low 14 day mortality risk who do not need to be hospitalized
arm group label: MR-proADM guided
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Juan Gonzalez del Castillo
role: Principal Investigator
affiliation: Hospital Clinico San Carlos
facility: 
facility: 
facility: 
facility: 
country: Spain
responsible party type: Sponsor
mesh term: Infections
mesh term: Communicable Diseases