Pharmacokinetic Study on Echinocandins for Patients With Septic Shock Following Secondary Peritonitis (EPI Study)

Centre Hospitalier Universitaire de Nīmes24 enrolled

Overview

The main objective of this study is to describe the pharmacokinetics of the prescribed echinocandins for septic shock with secondary peritonitis for which intra-abdominal fungal infection is suspected or proven.

The secondary objectives of this study are: * Determine whether the current recommended doses of caspofungin achieve the Pharmacokinetic/Pharmacodynamic (PK/PD) target for this molecule. * Determine whether the current recommended doses of micafungin achieve the PK / PD target for this molecule * Describe the peritoneal concentrations of echinocandins in secondary peritonitis complicated with septic shock * Identify via modeling PK / PD parameters and based on monte Carlo simulations the optimal dosing regimen for caspofungin and micafungin in this population

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Septic Shock Peritonitis

Interventions

EchinocandinsDRUG

The patients included in this protocol require routine treatment with caspofungin or micafungin. Though this intervention is under study, it is not modified by this protocol.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * The emergency inclusion procedure was correctly applied according to French law (signature of consent form by a patient-designated trusted person or a family member, or a medical decision to proceed with patient inclusion if the latter two persons are unavailable) ---- OR ---- signature of the consent form by the patient * The patient must be insured or beneficiary of a health insurance plan * The patient is 18 years of age or older * The patient has beed admitted to the ICU for septic shock accompanying secondary peritonitis * Patient requiring antifungal treatment via echinocandins (caspofungin or micafungin) * A venous or arterial access for blood sampling is already in place for routine care Exclusion Criteria: * The patient is participating in an interventional study that may affect the results of the present study, or has participated in such a study within the past 3 months * The patient is under judicial protection, or is an adult under guardianship * The patient is pregnant, parturient or breastfeeding * Moribund patient * Known positive serology for human immunodeficiency virus (HIV) * Known positive serology for hepatitis C * Known diagnosis for tuberculosis

Locations (2)

Royal Brisbane Women's Hospital

Herston, Australia

CHU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, France

Outcomes

Primary Outcomes

Antifungal treatment plasmatic clearance (L/h)

Time frame: Day 1

Antifungal treatment plasmatic clearance (L/h)

Time frame: Days 3-5

The volume of distribution (L) corresponding to plasmatic antifungal treatment concentration

Time frame: Day 1

The volume of distribution (L) corresponding to plasmatic antifungal treatment concentration

Time frame: Days 3-5

Intercompartmental transfer constant for a bi-compartmental model for plasmatic antifungal treatment concentration

Time frame: Day 1

Intercompartmental transfer constant for a bi-compartmental model for plasmatic antifungal treatment concentration

Time frame: Days 3-5

The area under the curve for plasmatic antifungal treatment concentrations

Time frame: Day 1

The area under the curve for plasmatic antifungal treatment concentrations

Time frame: Days 3-5

The maximum concentration for plasmatic antifungal treatment concentrations

Time frame: Day 1

The maximum concentration for plasmatic antifungal treatment concentrations

Time frame: Days 3-5

The minimum concentration for plasmatic antifungal treatment concentrations

Time frame: Day 1

Data from ClinicalTrials.gov

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Secondary Outcomes

The target Pharmacokinetic/Pharmacodynamic ratio for caspofungin

corresponds to: area under the curve / minimum inhibitory concentration \>865

Time frame: Day 1

The target Pharmacokinetic/Pharmacodynamic ratio for caspofungin

corresponds to: area under the curve / minimum inhibitory concentration \>865

Time frame: Days 3-5

The target Pharmacokinetic/Pharmacodynamic ratio for micafungin

corresponds to: area under the curve / minimum inhibitory concentration \>285 et 3000

Time frame: Day 1

The target Pharmacokinetic/Pharmacodynamic ratio for micafungin

corresponds to: area under the curve / minimum inhibitory concentration \>285 et 3000

Time frame: Days 3-5

The area under the curve for peritoneal antifungal treatment concentrations

Time frame: Day 1

The area under the curve for peritoneal antifungal treatment concentrations

Time frame: Days 3-5

The maximum concentration for peritoneal antifungal treatment concentrations

Time frame: Day 1

The maximum concentration for peritoneal antifungal treatment concentrations

Time frame: Days 3-5

The minimum concentration for peritoneal antifungal treatment concentrations

Time frame: Day 1

The minimum concentration for peritoneal antifungal treatment concentrations

Time frame: Days 3-5

The probability of attaining the targeted Pharmacokinetic/Pharmacodynamic ratio

Time frame: Day 1

The probability of attaining the targeted Pharmacokinetic/Pharmacodynamic ratio

Time frame: Days 3-5

The fraction of the probability of attaining the targeted Pharmacokinetic/Pharmacodynamic ratio

Time frame: Day 1

The fraction of the probability of attaining the targeted Pharmacokinetic/Pharmacodynamic ratio

Time frame: Days 3-5