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FPR-IIS: Predictive Factors of Mortality in Invasive Fungal Disease in Post-surgical Critical Care Unit

Sponsor
Hospital Universitario La Fe (Other)
Overall Status
Completed
CT.gov ID
NCT04484376
Collaborator
(none)
134
Enrollment
1
Location
32
Actual Duration (Months)
4.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    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.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    134 participants
    Observational Model:
    Other
    Time Perspective:
    Retrospective
    Official Title:
    Predictive Factors of Mortality in Invasive Fungal Disease in Post-surgical Critical Care Unit
    Actual Study Start Date :
    May 1, 2016
    Actual Primary Completion Date :
    Jan 1, 2019
    Actual Study Completion Date :
    Jan 1, 2019

    Arms and Interventions

    Arm Intervention/Treatment
    Other invasive candida infection

    Patients with invasive candida infection due a Candida specie othr than Candida Auris.
    Candida Auris related invasive infection

    Candida Auris related invasive candida infection.

    Outcome Measures

    Primary Outcome Measures

    1. Patients mortality [Hospital stay (up to 6 months)]

      Numeber of patients with fungal diseas related fatal outcome from diagnosis to end of hospital stay.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • More than 18 years

    • Admitted to the ICU that present fungal invasive disease

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hospital la Fe Valencia Spain 46026

    Sponsors and Collaborators

    • Hospital Universitario La Fe

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Oscar Diaz-Cambronero, Principal Investigator, Hospital Universitario La Fe
    ClinicalTrials.gov Identifier:
    NCT04484376
    Other Study ID Numbers:
    • FPR-IIS -029-02 Ed. 03
    First Posted:
    Jul 23, 2020
    Last Update Posted:
    Oct 29, 2020
    Last Verified:
    Oct 1, 2020
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Mycoses
    Invasive Fungal Infections

    Study Results

    No Results Posted as of Oct 29, 2020