- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04484376
Predictive Factors of Mortality in Invasive Fungal Disease in Post-surgical Critical Care Unit (FPR-IIS)
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.
Study Overview
Status
Conditions
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Valencia, Spain, 46026
- Hospital la Fe
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- More than 18 years
- Admitted to the ICU that present fungal invasive disease
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Other invasive candida infection
Patients with invasive candida infection due a Candida specie othr than Candida Auris.
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Candida Auris related invasive infection
Candida Auris related invasive candida infection.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Patients mortality
Time Frame: Hospital stay (up to 6 months)
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Number of patients with fungal disease related fatal outcome from diagnosis to end of hospital stay.
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Hospital stay (up to 6 months)
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- FPR-IIS -029-02 Ed. 03
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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