<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/NCT04484376</url>
  </required_header>
  <id_info>
    <org_study_id>FPR-IIS -029-02 Ed. 03</org_study_id>
    <nct_id>NCT04484376</nct_id>
  </id_info>
  <brief_title>Predictive Factors of Mortality in Invasive Fungal Disease in Post-surgical Critical Care Unit</brief_title>
  <acronym>FPR-IIS</acronym>
  <official_title>Predictive Factors of Mortality in Invasive Fungal Disease in Post-surgical Critical Care Unit</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospital Universitario La Fe</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospital Universitario La Fe</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>
      Invasive fungal disease in the critically ill patient is a serious complication that&#xD;
      increases hospitalization times, morbidity and mortality, and healthcare costs.&#xD;
&#xD;
      Our team proposes a retrospective observational study of patients from the resuscitation unit&#xD;
      of the Hospital la Fe who during the years 2016-2019 presented invasive candidiasis. The&#xD;
      investigators intend to detect if there are possible specific risk factors that favor the&#xD;
      development of invasive candidiasis in colonized patients and if these associated risk&#xD;
      factors could be considered as 'triggers' or alerts for the implementation of specific care&#xD;
      in these patients.&#xD;
&#xD;
      To do this, the investigators intend to study the blood samples taken from patients, taking&#xD;
      into account different types of perioperative variables from them, which will be&#xD;
      statistically analyzed, so that evidence-based inferences can be drawn to demonstrate our&#xD;
      hypothesis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The hypothesis is that there are factors predisposing to the development of invasive fungal&#xD;
      disease, invasive candidiasis, and that the detection of these factors may allow detecting&#xD;
      the population at risk and implementing both pharmacological measures and general strategies&#xD;
      to reduce the mortality of fungal infection.&#xD;
&#xD;
      Primary objective: To determine if candida auris is associated with increased risk of&#xD;
      mortality in invasive fungal disease and the risk factors for mortality in the invasive&#xD;
      fungal disease, including the species of candida that causes this disease.&#xD;
&#xD;
      Secondary objectives:&#xD;
&#xD;
      Determination of predictors of mortality in invasive fungal disease. Prepare and validate a&#xD;
      score in our environment that allows discriminating those patients with a high risk of&#xD;
      mortality.&#xD;
&#xD;
      To analyze the pharmacological management that has been carried out in patients who develop&#xD;
      candidemia due to auris.&#xD;
&#xD;
      Detect hospital stays of both population groups, in terms of health management.&#xD;
&#xD;
      Type of study: observational, longitudinal, and retrospective study of cases and controls of&#xD;
      a selected exposed population that developed the disease over time or not.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 1, 2016</start_date>
  <completion_date type="Actual">January 1, 2019</completion_date>
  <primary_completion_date type="Actual">January 1, 2019</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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Patients mortality</measure>
    <time_frame>Hospital stay (up to 6 months)</time_frame>
    <description>Numeber of patients with fungal diseas related fatal outcome from diagnosis to end of hospital stay.</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">134</enrollment>
  <condition>Fungal Invasive Disease</condition>
  <arm_group>
    <arm_group_label>Other invasive candida infection</arm_group_label>
    <description>Patients with invasive candida infection due a Candida specie othr than Candida Auris.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Candida Auris related invasive infection</arm_group_label>
    <description>Candida Auris related invasive candida infection.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        The population included in the study will be adult patients over 18 years admitted to the&#xD;
        Reanimation unit who present fungal invasive disease during their admission to the unit in&#xD;
        the period between May 2016 and January 2019.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  More than 18 years&#xD;
&#xD;
          -  Admitted to the ICU that present fungal invasive disease&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Hospital la Fe</name>
      <address>
        <city>Valencia</city>
        <zip>46026</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>October 2020</verification_date>
  <study_first_submitted>July 20, 2020</study_first_submitted>
  <study_first_submitted_qc>July 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 23, 2020</study_first_posted>
  <last_update_submitted>October 27, 2020</last_update_submitted>
  <last_update_submitted_qc>October 27, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">October 29, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hospital Universitario La Fe</investigator_affiliation>
    <investigator_full_name>Oscar Diaz-Cambronero</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Mycoses</mesh_term>
    <mesh_term>Invasive Fungal 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/NCT04484376
org study id: FPR-IIS -029-02 Ed. 03
nct id: NCT04484376
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Invasive fungal disease in the critically ill patient is a serious complication that
      increases hospitalization times, morbidity and mortality, and healthcare costs.

      Our team proposes a retrospective observational study of patients from the resuscitation unit
      of the Hospital la Fe who during the years 2016-2019 presented invasive candidiasis. The
      investigators intend to detect if there are possible specific risk factors that favor the
      development of invasive candidiasis in colonized patients and if these associated risk
      factors could be considered as 'triggers' or alerts for the implementation of specific care
      in these patients.

      To do this, the investigators intend to study the blood samples taken from patients, taking
      into account different types of perioperative variables from them, which will be
      statistically analyzed, so that evidence-based inferences can be drawn to demonstrate our
      hypothesis.
The hypothesis is that there are factors predisposing to the development of invasive fungal
      disease, invasive candidiasis, and that the detection of these factors may allow detecting
      the population at risk and implementing both pharmacological measures and general strategies
      to reduce the mortality of fungal infection.

      Primary objective: To determine if candida auris is associated with increased risk of
      mortality in invasive fungal disease and the risk factors for mortality in the invasive
      fungal disease, including the species of candida that causes this disease.

      Secondary objectives:

      Determination of predictors of mortality in invasive fungal disease. Prepare and validate a
      score in our environment that allows discriminating those patients with a high risk of
      mortality.

      To analyze the pharmacological management that has been carried out in patients who develop
      candidemia due to auris.

      Detect hospital stays of both population groups, in terms of health management.

      Type of study: observational, longitudinal, and retrospective study of cases and controls of
      a selected exposed population that developed the disease over time or not.
observational model: Other
time perspective: Retrospective
measure: Patients mortality
time frame: Hospital stay (up to 6 months)
description: Numeber of patients with fungal diseas related fatal outcome from diagnosis to end of hospital stay.
arm group label: Other invasive candida infection
description: Patients with invasive candida infection due a Candida specie othr than Candida Auris.
arm group label: Candida Auris related invasive infection
description: Candida Auris related invasive candida infection.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Spain
responsible party type: Principal Investigator
investigator affiliation: Hospital Universitario La Fe
investigator full name: Oscar Diaz-Cambronero
investigator title: Principal Investigator
mesh term: Mycoses
mesh term: Invasive Fungal Infections