De-escalation - Antifungal Treatment Immunocompromised Patients

Critical Illness Clinical Trial

— D-ATFIM  

Official title:

De-escalation of Antifungal Treatment in Immunocompromised Critically Ill Patients With Suspected Invasive Candida Infection: Incidence, Associated Factors, and Safety

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03774316
• Other study ID #: 2017_32
• Secondary ID: 2017-A03113-50
• Status: Recruiting
• Start date: January 28, 2019
• Est. completion date: September 2023

Study information

• Verified date: October 2022
• Source: University Hospital, Lille
• Contact: Saad Nseir, MD,PhD
• Phone: 03 20 44 44 95
• Email: saad.nseir[@]chru-lille.fr
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 296
• Est. completion date: September 2023
• Est. primary completion date: September 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Critical Illness
• Invasive Fungal Disease
• Invasive Fungal Infections
• Mycoses

Locations

Country	Name	City	State
France	CHU Lille	Lille

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Lille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Number of days free of mechanical ventilation	days with no mechanical ventilation	until day 28 after start of antifungal treatment
Secondary	Number of days free of antifungal treatment	days with no antifungal treatment	until day 28 after start of antifungal treatment
Secondary	Length of ICU stay	days in the ICU	until day 28 after start of antifungal treatment
Secondary	All-cause mortality	mortality related to any cause	until day 28 after start of antifungal treatment
Secondary	Percentage of patients with reoccurrence of candidiasis	reccurrence of candidiasis is defined as a new episode after the end of antifungal treatment	until day 7 after stop of antifungal treatment