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Screening Anti-Fungal Exposure in Intensive Care Units – The French Cohort

Phase 1
Conditions
The study will recruit patients in intensive care unit prescribed to receive any of the chosen systemic antifungal agents
MedDRA version: 20.0Level: SOCClassification code 10021881Term: Infections and infestationsSystem Organ Class: 10021881 - Infections and infestations
Therapeutic area: Not possible to specify
Registration Number
EUCTR2017-001433-74-FR
Lead Sponsor
CHU de NIMES
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Recruiting
Sex
All
Target Recruitment
40
Inclusion Criteria

•Age = 18
•Critically ill patients requiring ICU care
•Receiving systemic therapy of antifungal of interest (triazole, echinocandin, amphotericin) including prophylaxis indication and antifungal therapy started in another unit (wards, operating room) for the same infectious episode
•Availability of suitable intravenous/intra-arterial access to facilitate sample collection
•Written informed consent has been obtained from the patient or their next of kin or the patient has been included in emergency situation
•The patient must be insured or beneficiary of a health insurance plan

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion Criteria

•Aged < 18 years of age
•Pregnancy
•Consent not obtained (except in emergency situation)
•Diagnosis with human immunodeficiency virus or hepatitis B or C or tuberculosis

Study & Design

Study Type
Interventional clinical trial of medicinal product
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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