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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-28

Study Completion Date

2018-06-18

Brief Summary

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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.

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Detailed Description

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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

Conditions

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Septic Shock Peritonitis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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The study population

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).

Group Type EXPERIMENTAL

Echinocandins

Intervention Type DRUG

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.

Interventions

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Echinocandins

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.

Intervention Type DRUG

Other Intervention Names

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caspofungin or micafungin

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No