De-escalation - Antifungal Treatment Immunocompromised Patients

NCT03774316 | Completed

• 2 other identifiers: 2017_322017-A03113-50
• Study Type: observational
• Target: 275
• Locations: 1 country
• Sites: 1

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.

Conditions

Critical Illness; Invasive Fungal Disease

Keywords

De-escalation; Antifungal treatment; Mortality; Immunocompromised; Intensive care

Outcome Measures

Primary Outcomes (1)

• 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 (6)

• Risk factors for de-escalation of antifungal therapy

  during the 5 days following start of antifungal

• Number of days free of mechanical ventilation

  until day 28 after start of antifungal treatment

• Number of days free of antifungal treatment

  until day 28 after start of antifungal treatment

• Length of ICU stay

  until day 28 after start of antifungal treatment

• All-cause mortality

  until day 28 after start of antifungal treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Lille: lead

Study Sites (1)

CHU Lille

Lille, 59000, France

Location

MeSH Terms

Conditions

Invasive Fungal Infections; Critical Illness

Condition Hierarchy (Ancestors)

Mycoses; Bacterial Infections and Mycoses; Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Saad Nseir, MD,PhD

  University Hospital, Lille

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2018
• First Posted: December 12, 2018
• Study Start: January 28, 2019
• Primary Completion: November 7, 2023
• Study Completion: November 7, 2023
• Last Updated: December 23, 2025

Record last verified: 2025-12

Locations

FR (1)