Fungal Invasive DiseaseFPR-IISNCT04484376
Predictive Factors of Mortality in Invasive Fungal Disease in Post-surgical Critical Care Unit
An observational study of Fungal Invasive Disease, run by Hospital Universitario La Fe at 1 site in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fungal Invasive Disease
- How many people
- 134 participants
- Where
- 1 siteSpain
- Study dates
- 1 May 2016to 1 Jan 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The population included in the study will be adult patients over 18 years admitted to the Reanimation unit who present fungal invasive disease during their admission to the unit in the period between May 2016 and January 2019.
Who may be able to join
- More than 18 years
- Admitted to the ICU that present fungal invasive disease
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Fungal Invasive Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patients mortality
Number of patients with fungal disease related fatal outcome from diagnosis to end of hospital stay.
Measured: Hospital stay (up to 6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2020
- Study start1 May 2016
- Primary completion1 Jan 2019
- Study completion1 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fungal Invasive DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 134 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario La Fe
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Oscar Diaz-Cambronero, Hospital Universitario La Fe
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04484376
- Sponsor's protocol ID
- FPR-IIS -029-02 Ed. 03
- Acronym
- FPR-IIS
- Status last verified
- Mar 2024
- First submitted
- 20 Jul 2020
- Last updated
- 26 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Factors of Mortality in Invasive Fungal Disease in Post-surgical Critical Care Unit
- ClinicalTrials.gov ID
- NCT04484376
- Acronym / sponsor ID
- FPR-IIS / FPR-IIS -029-02 Ed. 03
- Conditions
- Fungal Invasive Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 134 participants (actual)
- Lead sponsor
- Hospital Universitario La FeUniversity, hospital or other
- Study start
- 1 May 2016 (actual)
- Primary completion
- 1 Jan 2019 (actual)
- Study completion
- 1 Jan 2019 (actual)
- First posted
- 23 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The population included in the study will be adult patients over 18 years admitted to the Reanimation unit who present fungal invasive disease during their admission to the unit in the period between May 2016 and January 2019.
Key inclusion criteria (2 listed)
- More than 18 years
- Admitted to the ICU that present fungal invasive disease
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Patients mortality
Time frame: Hospital stay (up to 6 months)
Number of patients with fungal disease related fatal outcome from diagnosis to end of hospital stay.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fungal Invasive Disease, run by Hospital Universitario La Fe at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patients mortality (time frame: Hospital stay (up to 6 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2024.