De-escalation - Antifungal Treatment Immunocompromised Pa... | NCT03774316

Studies
De-escalation - Antifungal Treatment Immunocompromised Patients

NCT03774316

Sponsor

University Hospital, Lille

Status

Completed

Last Update Posted

Dec 23, 2025Actual

Enrollment

275Actual

Phase

Not provided

Conditions

Invasive Fungal Disease
Critical Illness

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2017-A03113-50	Other Identifier	ID-RCB number, ANSM

Status Module

Record Verification Date

Dec 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 28, 2019Actual

Primary Completion Date

Nov 7, 2023Actual

Completion Date

Nov 7, 2023Actual

First Submitted Date

Dec 3, 2018

First Submission Date that Met QC Criteria

Dec 11, 2018

First Posted Date

Dec 12, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 16, 2025

Last Update Posted Date

Dec 23, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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. 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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

275Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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	5 days following start of antifungal treatment

Secondary Outcomes

Measure	Description	Time Frame
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	during the 5 days following start of antifungal

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder 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

Sampling Method

Non-Probability Sample

Name	Affiliation	Role
Saad Nseir, MD,PhD	University Hospital, Lille	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
CHU Lille		Lille		59000	France

Condition Browse Module

MeSH Terms

ID	Term
D000072742	Invasive Fungal Infections
D016638	Critical Illness

Ancestor Terms

ID	Term
D009181	Mycoses
D001423	Bacterial Infections and Mycoses
D007239	Infections
D020969	Disease Attributes

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