Invasive Fungal DiseaseD-ATFIMNCT03774316
De-escalation - Antifungal Treatment Immunocompromised Patients
An observational study of Invasive Fungal Disease and Critical Illness, run by University Hospital, Lille at 1 site in France.
Trial summary
A small proportion of intensive care unit patients receiving antifungals have a proven invasive fungal infection. However, antifungal treatment has side effects such as toxicity, emergence of resistance, and high cost. Moreover, empirical antifungal treatment is still a matter for debate in these patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Invasive Fungal Disease, Critical Illness
- How many people
- 275 participants
- Where
- 1 siteFrance
- Study dates
- 28 Jan 2019to 7 Nov 2023
- 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: Adults immunocompromised patients hospitalized in intensive care units (Age ≥18 years) Immunosuppression is defined by: * long-term immunosuppressive therapy (> 3 months) or high-dose corticosteroid therapy (> 0.5 mg / kg / day for at least 3 days) * Solid organ transplant * Solid cancer (active or in remission since <5 years) * Malignant haemopathy * HIV infection with CD4 <200
Who may be able to join
- Adults immunocompromised patients hospitalized in intensive care units
- Predictable invasive mechanical ventilation duration > 96h
- Signed consent (by patient or its representative)
- First antifungal treatment initiation in ICU for proven or suspected candida infection
Who cannot join
- Pregnant or breast-feeding women.
- Fungal infection other than invasive candida
- Prophylactic antifungal treatment.
- Lack of informed consent
- Predictable mechanical ventilation duration less than 48 hours
- Patients discharged from ICU before the 5th day after initiation of TAF
Trial locations and contacts
1 site in 1 country.
About this study
Official title: De-escalation of Antifungal Treatment in Immunocompromised Critically Ill Patients With Suspected Invasive Candida Infection: Incidence, Associated Factors, and Safety
A small proportion of intensive care unit patients receiving antifungals have a proven invasive fungal infection. However, antifungal treatment has side effects such as toxicity, emergence of resistance, and high cost. Moreover, empirical antifungal treatment is still a matter for debate in these patients. Our study aimed to determine the incidence, associated factors, and safety of de-escalation of antifungals in immunocompromised critically ill patients.
This prospective observational study is conducted in 14 ICU, during a 6 months period. All immunocompromised patients hospitalized for >5d and treated with antifungals for suspected or proven invasive candida infection will be included De-escalation is defined as a reduction in antifungal spectrum or stopping initial drugs within the 5 days following their initiation. The three antifungals considered in this study are from the narrowest to the widest spectrum: fluconazole, caspofungin and liposomal amphotericin B.
Read the detailed description
This is a retrospective and prospective observational multicenter study, aiming to determine the incidence, and safety of antifungal de-escalation in immunocompromised patients, and also factors associated with de-escalation.
- Conditions
- Invasive Fungal Disease, Critical Illness
- Keywords
- De-escalation, Antifungal treatment, Mortality, Immunocompromised, Intensive care
- Medical subject headings
- Invasive Fungal Infections, Critical Illness
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients with de-escalation of antifungal treatment
De-escalation is defined as a reduction in antifungal treatment spectrum (switch from echinocandines or Amphotericin B to Azoles) or stopping all antifungals within the 5 days following their initiation
Measured: 5 days following start of antifungal treatment
Secondary outcomes (6)
Risk factors for de-escalation of antifungal therapy
Clinical characteristics and conditions significantly associated with de-escalation by univariate analysis will be entered in a multiple regression model to determine those independently associated with de-escalation
Measured: during the 5 days following start of antifungal
Number of days free of mechanical ventilation
days with no mechanical ventilation
Measured: until day 28 after start of antifungal treatment
Number of days free of antifungal treatment
days with no antifungal treatment
Measured: until day 28 after start of antifungal treatment
Length of ICU stay
days in the ICU
Measured: until day 28 after start of antifungal treatment
All-cause mortality
mortality related to any cause
Measured: until day 28 after start of antifungal treatment
Percentage of patients with reoccurrence of candidiasis
reccurrence of candidiasis is defined as a new episode after the end of antifungal treatment
Measured: until day 7 after stop of antifungal treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2018
- Study start28 Jan 2019
- Primary completion7 Nov 2023
- Study completion7 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Invasive Fungal DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 275 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Saad Nseir, MD,PhD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03774316
- Sponsor's protocol ID
- 2017_32
- Other IDs
- 2017-A03113-50
- Acronym
- D-ATFIM
- Status last verified
- Dec 2025
- First submitted
- 3 Dec 2018
- Last updated
- 23 Dec 2025
- 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 23 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- De-escalation of Antifungal Treatment in Immunocompromised Critically Ill Patients With Suspected Invasive Candida Infection: Incidence, Associated Factors, and Safety
- ClinicalTrials.gov ID
- NCT03774316
- Acronym / sponsor ID
- D-ATFIM / 2017_32
- Conditions
- Invasive Fungal Disease, Critical Illness
- Keywords
- De-escalation, Antifungal treatment, Mortality, Immunocompromised, Intensive care
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 275 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- 28 Jan 2019 (actual)
- Primary completion
- 7 Nov 2023 (actual)
- Study completion
- 7 Nov 2023 (actual)
- First posted
- 12 Dec 2018 (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.
A small proportion of intensive care unit patients receiving antifungals have a proven invasive fungal infection. However, antifungal treatment has side effects such as toxicity, emergence of resistance, and high cost. Moreover, empirical antifungal treatment is still a matter for debate in these patients. Our study aimed to determine the incidence, associated factors, and safety of de-escalation of antifungals in immunocompromised critically ill patients.
This prospective observational study is conducted in 14 ICU, during a 6 months period. All immunocompromised patients hospitalized for >5d and treated with antifungals for suspected or proven invasive candida infection will be included De-escalation is defined as a reduction in antifungal spectrum or stopping initial drugs within the 5 days following their initiation. The three antifungals considered in this study are from the narrowest to the widest spectrum: fluconazole, caspofungin and liposomal amphotericin B.
Detailed description
This is a retrospective and prospective observational multicenter study, aiming to determine the incidence, and safety of antifungal de-escalation in immunocompromised patients, and also factors associated with de-escalation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults immunocompromised patients hospitalized in intensive care units (Age ≥18 years) Immunosuppression is defined by: * long-term immunosuppressive therapy (> 3 months) or high-dose corticosteroid therapy (> 0.5 mg / kg / day for at least 3 days) * Solid organ transplant * Solid cancer (active or in remission since <5 years) * Malignant haemopathy * HIV infection with CD4 <200
Key inclusion criteria (4 listed)
- Adults immunocompromised patients hospitalized in intensive care units
- Predictable invasive mechanical ventilation duration > 96h
- Signed consent (by patient or its representative)
- First antifungal treatment initiation in ICU for proven or suspected candida infection
Key exclusion criteria (6 listed)
- Pregnant or breast-feeding women.
- Fungal infection other than invasive candida
- Prophylactic antifungal treatment.
- Lack of informed consent
- Predictable mechanical ventilation duration less than 48 hours
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
Percentage of patients with de-escalation of antifungal treatment
Time frame: 5 days following start of antifungal treatment
De-escalation is defined as a reduction in antifungal treatment spectrum (switch from echinocandines or Amphotericin B to Azoles) or stopping all antifungals within the 5 days following their initiation
6 secondary outcomes
Risk factors for de-escalation of antifungal therapy
Time frame: during the 5 days following start of antifungal
Number of days free of mechanical ventilation
Time frame: until day 28 after start of antifungal treatment
Number of days free of antifungal treatment
Time frame: until day 28 after start of antifungal treatment
Length of ICU stay
Time frame: until day 28 after start of antifungal treatment
All-cause mortality
Time frame: until day 28 after start of antifungal treatment
Percentage of patients with reoccurrence of candidiasis
Time frame: until day 7 after stop of antifungal treatment
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 23 Dec 2025.
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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.
Saad Nseir, MD,PhD principal investigator
University Hospital, Lille
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 Invasive Fungal Disease and Critical Illness, run by University Hospital, Lille at 1 site in France.
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 4 inclusion and 6 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 23 Dec 2025. 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 France. 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?
Percentage of patients with de-escalation of antifungal treatment (time frame: 5 days following start of antifungal treatment). 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 23 Dec 2025.