Critical Illness, Fungal Infection
Conditions
Keywords
empiric antifungal therapy, biomarkers, invasive fungal infection, Candida
Brief summary
The investigators hypothesized that the use of biomarkers of invasive fungal infections would increase the percentage of early discontinuation of empirical antifungal therapy and thus reduce the duration of treatment in ICU patients.
Detailed description
The duration of empirical/preemptive anti fungal treatment will be based in the intervention group on biomarker results. Biomarkers of fungal disease will performed before starting anti fungal treatment and at day 4.
Interventions
OTHERBiomarker group
use of invasive fungal disease biomarkers (β-1,3-glucan, mannan/anti-mannan antibodies)
Sponsors
University Hospital, Lille
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age \> or = 18 years * Patients requiring empiric antifungal therapy the first time in the ICU * Predictable duration of hospitalization in the ICU ≥ 6 days
Exclusion criteria
* Neutropenia (WBC \<1000 or neutrophils \<500/mm3) * Immunosuppressive therapy (chemotherapy within 3 months prior to the ICU admission, solid organ graft under immunosuppressive therapy) * invasive fungal infection documented in the three previous months * Antifungal treatment in the three previous months * Pregnant or lactating women
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| percentage of early discontinuation of empiric antifungal therapy | 7 days | Early discontinuation is defined as discontinuation of anti fungal treatment before the 7th day after the start of treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| mortality in ICU | 28 days after ICU admission | death during the 28 days following ICU admission |
| duration of mechanical ventilation and ICU stay | 28 days after ICU admission | mechanical ventilation duration during the 28 days following ICU admission |
| fungal colonization / infection after antifungal therapy, with or without resistant strains | 28 days after ICU admission | Any fungal colonization or infection diagnosed during the 28 days following ICU admission |
| the cost of the antifungal therapy on a per duration prescribe | 28 days after ICU admission | — |
| the cost of hospital stays | 28 days after ICU admission | — |
Countries
France
Contacts
PRINCIPAL_INVESTIGATORSaad Nseir, MD, PhD
Univ Hosp of Lille, France
Outcome results
None listed