Critical Illness, Invasive Fungal Disease
Conditions
Keywords
De-escalation, Antifungal treatment, Mortality, Immunocompromised, Intensive care
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.
Interventions
None listed
Sponsors
University Hospital, Lille
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Number of days free of mechanical ventilation | until day 28 after start of antifungal treatment | days with no mechanical ventilation |
| 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 |
| 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 |
| Length of ICU stay | until day 28 after start of antifungal treatment | days in the ICU |
Countries
France
Outcome results
None listed