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

December 3, 2025 updated by: Centre Hospitalier Universitaire de Nīmes

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
24

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Herston, Australia, 4029
        • Royal Brisbane Women's Hospital
  • France
      • Nîmes, France, 30029
        • CHU de Nîmes - Hopital Universitaire Caremeau

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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).
Drug: 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.
Other Names:
  • caspofungin or micafungin

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Antifungal treatment plasmatic clearance (L/h)
Time Frame: Day 1
Day 1
Antifungal treatment plasmatic clearance (L/h)
Time Frame: Days 3-5
Days 3-5
The volume of distribution (L) corresponding to plasmatic antifungal treatment concentration
Time Frame: Day 1
Day 1
The volume of distribution (L) corresponding to plasmatic antifungal treatment concentration
Time Frame: Days 3-5
Days 3-5
Intercompartmental transfer constant for a bi-compartmental model for plasmatic antifungal treatment concentration
Time Frame: Day 1
Day 1
Intercompartmental transfer constant for a bi-compartmental model for plasmatic antifungal treatment concentration
Time Frame: Days 3-5
Days 3-5
The area under the curve for plasmatic antifungal treatment concentrations
Time Frame: Day 1
Day 1
The area under the curve for plasmatic antifungal treatment concentrations
Time Frame: Days 3-5
Days 3-5
The maximum concentration for plasmatic antifungal treatment concentrations
Time Frame: Day 1
Day 1
The maximum concentration for plasmatic antifungal treatment concentrations
Time Frame: Days 3-5
Days 3-5
The minimum concentration for plasmatic antifungal treatment concentrations
Time Frame: Day 1
Day 1
The minimum concentration for plasmatic antifungal treatment concentrations
Time Frame: Days 3-5
Days 3-5

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The target Pharmacokinetic/Pharmacodynamic ratio for caspofungin
Time Frame: Day 1
corresponds to: area under the curve / minimum inhibitory concentration >865
Day 1
The target Pharmacokinetic/Pharmacodynamic ratio for caspofungin
Time Frame: Days 3-5
corresponds to: area under the curve / minimum inhibitory concentration >865
Days 3-5
The target Pharmacokinetic/Pharmacodynamic ratio for micafungin
Time Frame: Day 1
corresponds to: area under the curve / minimum inhibitory concentration >285 et 3000
Day 1
The target Pharmacokinetic/Pharmacodynamic ratio for micafungin
Time Frame: Days 3-5
corresponds to: area under the curve / minimum inhibitory concentration >285 et 3000
Days 3-5
The area under the curve for peritoneal antifungal treatment concentrations
Time Frame: Day 1
Day 1
The area under the curve for peritoneal antifungal treatment concentrations
Time Frame: Days 3-5
Days 3-5
The maximum concentration for peritoneal antifungal treatment concentrations
Time Frame: Day 1
Day 1
The maximum concentration for peritoneal antifungal treatment concentrations
Time Frame: Days 3-5
Days 3-5
The minimum concentration for peritoneal antifungal treatment concentrations
Time Frame: Day 1
Day 1
The minimum concentration for peritoneal antifungal treatment concentrations
Time Frame: Days 3-5
Days 3-5
The probability of attaining the targeted Pharmacokinetic/Pharmacodynamic ratio
Time Frame: Day 1
Day 1
The probability of attaining the targeted Pharmacokinetic/Pharmacodynamic ratio
Time Frame: Days 3-5
Days 3-5
The fraction of the probability of attaining the targeted Pharmacokinetic/Pharmacodynamic ratio
Time Frame: Day 1
Day 1
The fraction of the probability of attaining the targeted Pharmacokinetic/Pharmacodynamic ratio
Time Frame: Days 3-5
Days 3-5

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Centre Hospitalier Universitaire de Nīmes

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Claire Roger, MD, Centre Hospitalier Universitaire de Nīmes

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 28, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 18, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 18, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 15, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 15, 2016

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 17, 2016

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 10, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 3, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • LOCAL/2016/CR-01
  • 2016-002708-17 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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