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

Phase 4

Completed

• Conditions: Peritonitis; Septic Shock
• Interventions: Drug: Echinocandins

• Registration Number: NCT02805049
• Lead Sponsor: Centre Hospitalier Universitaire de Nīmes

Brief Summary

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.

Detailed Description

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 Timeline

• Study First Submitted: 2016-06-15
• Study First Submitted QC: 2016-06-15
• Study First Posted: 2016-06-17
• Study Start: 2017-01-28
• Primary Completion: 2018-06-23
• Study Completion: 2018-06-23
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-24
• Last Update Posted: 2019-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
The study population	Echinocandins	The study population consisted of patients admitted to the ICU for septic shock associated with secondary peritonitis and requiring antifungal therapy via echinocandins (micafungin or caspofungin).

Primary Outcome Measures

Name	Time	Method
The volume of distribution (L) corresponding to plasmatic antifungal treatment concentration	Days 3-5
Intercompartmental transfer constant for a bi-compartmental model for plasmatic antifungal treatment concentration	Days 3-5
The minimum concentration for plasmatic antifungal treatment concentrations	Days 3-5
The area under the curve for plasmatic antifungal treatment concentrations	Days 3-5
Antifungal treatment plasmatic clearance (L/h)	Days 3-5
The maximum concentration for plasmatic antifungal treatment concentrations	Days 3-5

Secondary Outcome Measures

Name	Time	Method
The area under the curve for peritoneal antifungal treatment concentrations	Days 3-5
The probability of attaining the targeted Pharmacokinetic/Pharmacodynamic ratio	Days 3-5
The target Pharmacokinetic/Pharmacodynamic ratio for caspofungin	Days 3-5	corresponds to: area under the curve / minimum inhibitory concentration \>865
The target Pharmacokinetic/Pharmacodynamic ratio for micafungin	Days 3-5	corresponds to: area under the curve / minimum inhibitory concentration \>285 et 3000
The fraction of the probability of attaining the targeted Pharmacokinetic/Pharmacodynamic ratio	Days 3-5
The maximum concentration for peritoneal antifungal treatment concentrations	Days 3-5
The minimum concentration for peritoneal antifungal treatment concentrations	Days 3-5

Trial Locations

Locations (2)

Royal Brisbane Women's Hospital; 🇦🇺 Herston, Australia

CHU de Nîmes - Hôpital Universitaire Carémeau; 🇫🇷 Nîmes Cedex 09, France