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Completed

NCT Number: NCT02805049

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

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Royal Brisbane Women's Hospital, Herston, Australia

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Echinocandins

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.

Other names: caspofungin or micafungin

Primary outcomes

  1. Antifungal treatment plasmatic clearance (L/h)

    Time frame: Day 1

  2. Antifungal treatment plasmatic clearance (L/h)

    Time frame: Days 3-5

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

    Time frame: Day 1

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

    Time frame: Days 3-5

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

    Time frame: Day 1

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

    Time frame: Days 3-5

  7. The area under the curve for plasmatic antifungal treatment concentrations

    Time frame: Day 1

  8. The area under the curve for plasmatic antifungal treatment concentrations

    Time frame: Days 3-5

  9. The maximum concentration for plasmatic antifungal treatment concentrations

    Time frame: Day 1

  10. The maximum concentration for plasmatic antifungal treatment concentrations

    Time frame: Days 3-5

  11. The minimum concentration for plasmatic antifungal treatment concentrations

    Time frame: Day 1

  12. The minimum concentration for plasmatic antifungal treatment concentrations

    Time frame: Days 3-5

Secondary outcomes

  1. The target Pharmacokinetic/Pharmacodynamic ratio for caspofungin

    Time frame: Day 1

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

  2. The target Pharmacokinetic/Pharmacodynamic ratio for caspofungin

    Time frame: Days 3-5

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

  3. The target Pharmacokinetic/Pharmacodynamic ratio for micafungin

    Time frame: Day 1

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

  4. The target Pharmacokinetic/Pharmacodynamic ratio for micafungin

    Time frame: Days 3-5

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

  5. The area under the curve for peritoneal antifungal treatment concentrations

    Time frame: Day 1

  6. The area under the curve for peritoneal antifungal treatment concentrations

    Time frame: Days 3-5

  7. The maximum concentration for peritoneal antifungal treatment concentrations

    Time frame: Day 1

  8. The maximum concentration for peritoneal antifungal treatment concentrations

    Time frame: Days 3-5

  9. The minimum concentration for peritoneal antifungal treatment concentrations

    Time frame: Day 1

  10. The minimum concentration for peritoneal antifungal treatment concentrations

    Time frame: Days 3-5

  11. The probability of attaining the targeted Pharmacokinetic/Pharmacodynamic ratio

    Time frame: Day 1

  12. The probability of attaining the targeted Pharmacokinetic/Pharmacodynamic ratio

    Time frame: Days 3-5

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

    Time frame: Day 1

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

    Time frame: Days 3-5

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nīmes

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jun 17, 2016
Registry last updated
Dec 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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