Septic ShockPhase 4NCT02805049
Pharmacokinetic Study on Echinocandins for Patients With Septic Shock Following Secondary Peritonitis (EPI Study)
A Phase 4 study testing Echinocandins in people with Septic Shock and Peritonitis, run by Centre Hospitalier Universitaire de Nīmes at 2 sites in 2 countries.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Septic Shock, Peritonitis
- What is being tested?
- Echinocandins
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 28 Jan 2017to 18 Jun 2018
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: 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.
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
- Conditions
- Septic Shock, Peritonitis
- Being tested
- Echinocandins
- Medical subject headings
- Shock, Septic, Peritonitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EchinocandinsDrug
Also called caspofungin or micafungin
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.
| Study group | Role | What they receive |
|---|---|---|
| The study population | Experimental | 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). Receives: Drug: Echinocandins |
What is being measured
The primary outcome is the main question the study is designed to answer.
Antifungal treatment plasmatic clearance (L/h)
Measured: Day 1
Antifungal treatment plasmatic clearance (L/h)
Measured: Days 3-5
The volume of distribution (L) corresponding to plasmatic antifungal treatment concentration
Measured: Day 1
The volume of distribution (L) corresponding to plasmatic antifungal treatment concentration
Measured: Days 3-5
Intercompartmental transfer constant for a bi-compartmental model for plasmatic antifungal treatment concentration
Measured: Day 1
Intercompartmental transfer constant for a bi-compartmental model for plasmatic antifungal treatment concentration
Measured: Days 3-5
The area under the curve for plasmatic antifungal treatment concentrations
Measured: Day 1
The area under the curve for plasmatic antifungal treatment concentrations
Measured: Days 3-5
The maximum concentration for plasmatic antifungal treatment concentrations
Measured: Day 1
The maximum concentration for plasmatic antifungal treatment concentrations
Measured: Days 3-5
The minimum concentration for plasmatic antifungal treatment concentrations
Measured: Day 1
The minimum concentration for plasmatic antifungal treatment concentrations
Measured: Days 3-5
Secondary outcomes (14)
The target Pharmacokinetic/Pharmacodynamic ratio for caspofungin
corresponds to: area under the curve / minimum inhibitory concentration >865
Measured: Day 1
The target Pharmacokinetic/Pharmacodynamic ratio for caspofungin
corresponds to: area under the curve / minimum inhibitory concentration >865
Measured: Days 3-5
The target Pharmacokinetic/Pharmacodynamic ratio for micafungin
corresponds to: area under the curve / minimum inhibitory concentration >285 et 3000
Measured: Day 1
The target Pharmacokinetic/Pharmacodynamic ratio for micafungin
corresponds to: area under the curve / minimum inhibitory concentration >285 et 3000
Measured: Days 3-5
The area under the curve for peritoneal antifungal treatment concentrations
Measured: Day 1
The area under the curve for peritoneal antifungal treatment concentrations
Measured: Days 3-5
The maximum concentration for peritoneal antifungal treatment concentrations
Measured: Day 1
The maximum concentration for peritoneal antifungal treatment concentrations
Measured: Days 3-5
The minimum concentration for peritoneal antifungal treatment concentrations
Measured: Day 1
The minimum concentration for peritoneal antifungal treatment concentrations
Measured: Days 3-5
The probability of attaining the targeted Pharmacokinetic/Pharmacodynamic ratio
Measured: Day 1
The probability of attaining the targeted Pharmacokinetic/Pharmacodynamic ratio
Measured: Days 3-5
The fraction of the probability of attaining the targeted Pharmacokinetic/Pharmacodynamic ratio
Measured: Day 1
The fraction of the probability of attaining the targeted Pharmacokinetic/Pharmacodynamic ratio
Measured: Days 3-5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2016 (estimated)
- Study start28 Jan 2017
- Primary completion18 Jun 2018
- Study completion18 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Septic ShockStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Claire Roger, MD, Principal investigator, Centre Hospitalier Universitaire de Nīmes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02805049
- Sponsor's protocol ID
- LOCAL/2016/CR-01
- Other IDs
- 2016-002708-17, 2016
- Status last verified
- Jan 2019
- First submitted
- 15 Jun 2016
- Last updated
- 10 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetic Study on Echinocandins for Patients With Septic Shock Following Secondary Peritonitis
- ClinicalTrials.gov ID
- NCT02805049
- Acronym / sponsor ID
- LOCAL/2016/CR-01
- Conditions
- Septic Shock, Peritonitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- 28 Jan 2017 (actual)
- Primary completion
- 18 Jun 2018 (actual)
- Study completion
- 18 Jun 2018 (actual)
- First posted
- 17 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| The study population | Experimental | Drug: EchinocandinsThe 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EchinocandinsAlso: caspofungin or micafunginThe 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. | Drug | The study population |
Primary outcome
Antifungal treatment plasmatic clearance (L/h)
Time frame: Day 1
Antifungal treatment plasmatic clearance (L/h)
Time frame: Days 3-5
The volume of distribution (L) corresponding to plasmatic antifungal treatment concentration
Time frame: Day 1
The volume of distribution (L) corresponding to plasmatic antifungal treatment concentration
Time frame: Days 3-5
Intercompartmental transfer constant for a bi-compartmental model for plasmatic antifungal treatment concentration
Time frame: Day 1
Intercompartmental transfer constant for a bi-compartmental model for plasmatic antifungal treatment concentration
Time frame: Days 3-5
The area under the curve for plasmatic antifungal treatment concentrations
Time frame: Day 1
The area under the curve for plasmatic antifungal treatment concentrations
Time frame: Days 3-5
The maximum concentration for plasmatic antifungal treatment concentrations
Time frame: Day 1
The maximum concentration for plasmatic antifungal treatment concentrations
Time frame: Days 3-5
The minimum concentration for plasmatic antifungal treatment concentrations
Time frame: Day 1
The minimum concentration for plasmatic antifungal treatment concentrations
Time frame: Days 3-5
14 secondary outcomes
The target Pharmacokinetic/Pharmacodynamic ratio for caspofungin
Time frame: Day 1
The target Pharmacokinetic/Pharmacodynamic ratio for caspofungin
Time frame: Days 3-5
The target Pharmacokinetic/Pharmacodynamic ratio for micafungin
Time frame: Day 1
The target Pharmacokinetic/Pharmacodynamic ratio for micafungin
Time frame: Days 3-5
The area under the curve for peritoneal antifungal treatment concentrations
Time frame: Day 1
The area under the curve for peritoneal antifungal treatment concentrations
Time frame: Days 3-5
The maximum concentration for peritoneal antifungal treatment concentrations
Time frame: Day 1
The maximum concentration for peritoneal antifungal treatment concentrations
Time frame: Days 3-5
The minimum concentration for peritoneal antifungal treatment concentrations
Time frame: Day 1
The minimum concentration for peritoneal antifungal treatment concentrations
Time frame: Days 3-5
The probability of attaining the targeted Pharmacokinetic/Pharmacodynamic ratio
Time frame: Day 1
The probability of attaining the targeted Pharmacokinetic/Pharmacodynamic ratio
Time frame: Days 3-5
The fraction of the probability of attaining the targeted Pharmacokinetic/Pharmacodynamic ratio
Time frame: Day 1
The fraction of the probability of attaining the targeted Pharmacokinetic/Pharmacodynamic ratio
Time frame: Days 3-5
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2025.
- Results publication: PubMed 33846133Garbez 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Claire Roger, MD principal investigator
Centre Hospitalier Universitaire de Nīmes
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Echinocandins in people with Septic Shock and Peritonitis, run by Centre Hospitalier Universitaire de Nīmes at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Australia, France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Antifungal treatment plasmatic clearance (L/h) (time frame: Day 1). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02805049, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2025.