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CompletedNCT02805049Updated Dec 10, 2025

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

A Phase 4 interventional study of Echinocandins in Septic Shock and Peritonitis, sponsored by Centre Hospitalier Universitaire de Nīmes. Completed at 2 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-10.

Sponsored by Centre Hospitalier Universitaire de Nīmes · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
24
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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
02

Conditions studied

  • Septic Shock
  • Peritonitis
03

In context

Shock, Septic

1,078 studies on the registry are indexed under Shock, Septic; 232 are open to participants now.

This study's enrollment of 24 is below the median of 79 across 636 interventional studies indexed under Shock, Septic.

Browse Shock, Septic studies →

Lead sponsor

Centre Hospitalier Universitaire de Nīmes is the lead sponsor of 595 studies on the registry; 90 are open to participants now.

Browse Centre Hospitalier Universitaire de Nīmes studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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 (HIV)
  • Known positive serology for
  • Known diagnosis for tuberculosis
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
24 participants (actual)

Study arms

  • 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

Interventions

  • DrugEchinocandins

    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.

    Also known as: caspofungin or micafungin

06

What researchers measure

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

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

    Time frame: Day 1

  2. The target Pharmacokinetic/Pharmacodynamic ratio for caspofungin

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

    Time frame: Days 3-5

  3. The target Pharmacokinetic/Pharmacodynamic ratio for micafungin

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

    Time frame: Day 1

  4. The target Pharmacokinetic/Pharmacodynamic ratio for micafungin

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

    Time frame: Days 3-5

  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

07

Study locations

2 sites
  • Royal Brisbane Women's Hospital
    Herston, 4029, Australia
  • CHU de Nîmes - Hôpital Universitaire Carémeau
    Nîmes, 30029, France
08

References and documents

Publications

  • Garbez N, Mbatchi L, Wallis SC, Muller L, Lipman J, Roberts JA, Lefrant JY, Roger C. Prospective Cohort Study of Micafungin Population Pharmacokinetic Analysis in Plasma and Peritoneal Fluid in Septic Patients with Intra-abdominal Infections. Antimicrob Agents Chemother. 2021 Jun 17;65(7):e0230720. doi: 10.1128/AAC.02307-20. Epub 2021 Jun 17. PubMed 33846133 ↗
09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jan 2017 to primary completion in Jun 2018, 16 months.

Of 39 non-industry phase 4 interventional studies under Shock, Septic, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 38. This study's 16 months is below that.

Counting every sponsor, half of 40 studies reached it within 24 months; a quarter within 16 and three quarters within 38.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 15, 2016
First posted
Jun 17, 2016
StartActual
Jan 28, 2017
Primary completionActual
Jun 18, 2018
CompletionActual
Jun 18, 2018
Last update
Dec 10, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 10, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02805049
Lead sponsor
Centre Hospitalier Universitaire de Nīmes
Responsible party
Sponsor
First posted
Jun 17, 2016
Start date
Jan 28, 2017
Primary completion
Jun 18, 2018
Completion
Jun 18, 2018
Last update
Dec 10, 2025

Study contacts

Claire Roger, MD
principal investigator · Centre Hospitalier Universitaire de Nīmes

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.

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