De-escalation - Antifungal Treatment Immunocompromised Patients

Recruiting

• Conditions: Critical Illness; Invasive Fungal Disease

• Registration Number: NCT03774316
• Lead Sponsor: University Hospital, Lille

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.

Study Timeline

• Study First Submitted: 2018-12-03
• Study First Submitted QC: 2018-12-11
• Study First Posted: 2018-12-12
• Study Start: 2019-01-28
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-14
• Last Update Posted: 2022-10-17
• Primary Completion: 2023-09
• Study Completion: 2023-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 296

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of patients with de-escalation of antifungal treatment	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

Secondary Outcome Measures

Name	Time	Method
Number of days free of mechanical ventilation	until day 28 after start of antifungal treatment	days with no mechanical ventilation
All-cause mortality	until day 28 after start of antifungal treatment	mortality related to any cause
Percentage of patients with reoccurrence of candidiasis	until day 7 after stop of antifungal treatment	reccurrence of candidiasis is defined as a new episode after the end of antifungal treatment
Number of days free of antifungal treatment	until day 28 after start of antifungal treatment	days with no antifungal treatment
Risk factors for de-escalation of antifungal therapy	during the 5 days following start of antifungal	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
Length of ICU stay	until day 28 after start of antifungal treatment	days in the ICU

Trial Locations

Locations (1)

CHU Lille; 🇫🇷 Lille, France