Actively Recruiting
Early Discontinuation of Empirical Antifungal Therapy and Biomarkers
Led by University Hospital, Lille · Updated on 2024-05-16
194
Participants Needed
10
Research Sites
364 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Empirical antifungal therapy (EAT) is frequently prescribed to septic critically ill patients with risk factors for invasive Candida infections (ICI). However, among patients without subsequent proven ICI, antifungal discontinuation is rarely performed, resulting in unnecessary antifungal overuse. The investigators postulate that the use of fungal biomarkers could increase the percentage of early discontinuation of EAT among critically ill patients suspected of ICI, as compared with a standard strategy, without negative impact on day 28-mortality. To test this hypothesis, the investigators designed a randomized controlled open-label parallel-group study.
CONDITIONS
Official Title
Early Discontinuation of Empirical Antifungal Therapy and Biomarkers
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient older than 18 years
- Requires empirical antifungal therapy for the first time in the ICU
- Expected ICU stay of at least 6 days after starting antifungal therapy
- Provides informed written consent
You will not qualify if you...
- Neutropenia with neutrophil count below 500 cells/µL
- Active malignant blood cancer
- Bone marrow transplantation in the last 6 months
- Received polyvalent immunoglobulins in recent months
- Documented invasive Candida infection in the past 3 months
- Pregnancy or breastfeeding
AI-Screening
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Trial Site Locations
Total: 10 locations
1
CH ARRAS
Arras, France
Actively Recruiting
2
CH de DOUAI
Douai, France
Actively Recruiting
3
CH Dunkerque
Dunkirk, France
Actively Recruiting
4
Centre Hospitalier Dr Schaffner
Lens, France
Actively Recruiting
5
Ch Dr.Schaffner de Lens
Lens, France
Actively Recruiting
6
Hôpital Roger Salengro, CHU
Lille, France
Actively Recruiting
7
CH Roubaix
Roubaix, France
Actively Recruiting
8
CHU de Rouen
Rouen, France
Actively Recruiting
9
Ch Tourcoing
Tourcoing, France
Actively Recruiting
10
Centre hospitalier de valenciennes
Valenciennes, France
Actively Recruiting
Research Team
A
Anahita Rouze, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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