The study will recruit patients in intensive care unit prescribed to receive any of the chosen systemic antifungal agents MedDRA version: 20.0 Level: SOC Classification code 10021881 Term: Infections and infestations System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Trade Name: AmBisome Liposomal Amphotericin B 50mg Powder for Concentrate for Dispersion
for Infusion.
Pharmaceutical Form: Powder for concentrate for dispersion for infusion
Trade Name: ECALTA 100
Sponsors
CHU de NIMES
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The overall objective of this study is to describe whether contemporary dosing of anti-fungal drugs achieves pharmacokinetic/pharmacodynamics (PK/PD) targets associated with optimal outcome;Secondary Objective: •To assess whether observed plasma concentrations of antifungals are adequate to attain PK/PD targets associated with optimal outcomes •To describe the variability of anti-fungal drug concentrations amongst patients •To describe the relationship between observed anti-fungal drug concentrations and different clinical covariates •To identify whether achievement of PK/PD targets is associated with improved clinical outcomes •To describe the population pharmacokinetics of individual antifungal drugs in specific subgroups of patients •To describe the observed antifungal peritoneal concentrations in the subgroup of patients with peritonitis ;Primary end point(s): The primary endpoint for outcome assessment will be the attainment of PK/PD targets associated with optimal efficacy. Predefined breakpoints will be used when well defined (EUCAST, CLSI breakpoints) and animal models or in vitro data will be used when breakpoints are not defined to determine PK/PD targets.;Timepoint(s) of evaluation of this end point: 7 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • To assess whether observed plasma concentrations of antifungals are adequate to attain PK/PD targets associated with optimal outcomes • To describe the variability of anti-fungal drug concentrations amongst patients • To describe the relationship between observed anti-fungal drug concentrations and different clinical covariates • To identify whether achievement of PK/PD targets is associated with improved clinical outcomes • To describe the population pharmacokinetics of individual antifungal drugs in specific subgroups of patients • To describe the observed antifungal peritoneal concentrations in the subgroup of patients with peritonitis;Timepoint(s) of evaluation of this end point: J7 | — |
Countries
France
Contacts
Public ContactDRCI
CHU de NIMES
Outcome results
None listed