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

Primary Purpose

Septic Shock, Peritonitis

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Echinocandins
Sponsored by
Centre Hospitalier Universitaire de Nīmes
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Septic Shock

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Royal Brisbane Women's Hospital
  • CHU de Nîmes - Hôpital Universitaire Carémeau

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

The study population

Arm Description

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).

Outcomes

Primary Outcome Measures

Antifungal treatment plasmatic clearance (L/h)
Antifungal treatment plasmatic clearance (L/h)
The volume of distribution (L) corresponding to plasmatic antifungal treatment concentration
The volume of distribution (L) corresponding to plasmatic antifungal treatment concentration
Intercompartmental transfer constant for a bi-compartmental model for plasmatic antifungal treatment concentration
Intercompartmental transfer constant for a bi-compartmental model for plasmatic antifungal treatment concentration
The area under the curve for plasmatic antifungal treatment concentrations
The area under the curve for plasmatic antifungal treatment concentrations
The maximum concentration for plasmatic antifungal treatment concentrations
The maximum concentration for plasmatic antifungal treatment concentrations
The minimum concentration for plasmatic antifungal treatment concentrations
The minimum concentration for plasmatic antifungal treatment concentrations

Secondary Outcome Measures

The target Pharmacokinetic/Pharmacodynamic ratio for caspofungin
corresponds to: area under the curve / minimum inhibitory concentration >865
The target Pharmacokinetic/Pharmacodynamic ratio for caspofungin
corresponds to: area under the curve / minimum inhibitory concentration >865
The target Pharmacokinetic/Pharmacodynamic ratio for micafungin
corresponds to: area under the curve / minimum inhibitory concentration >285 et 3000
The target Pharmacokinetic/Pharmacodynamic ratio for micafungin
corresponds to: area under the curve / minimum inhibitory concentration >285 et 3000
The area under the curve for peritoneal antifungal treatment concentrations
The area under the curve for peritoneal antifungal treatment concentrations
The maximum concentration for peritoneal antifungal treatment concentrations
The maximum concentration for peritoneal antifungal treatment concentrations
The minimum concentration for peritoneal antifungal treatment concentrations
The minimum concentration for peritoneal antifungal treatment concentrations
The probability of attaining the targeted Pharmacokinetic/Pharmacodynamic ratio
The probability of attaining the targeted Pharmacokinetic/Pharmacodynamic ratio
The fraction of the probability of attaining the targeted Pharmacokinetic/Pharmacodynamic ratio
The fraction of the probability of attaining the targeted Pharmacokinetic/Pharmacodynamic ratio

Full Information

First Posted
June 15, 2016
Last Updated
January 24, 2019
Sponsor
Centre Hospitalier Universitaire de Nīmes
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1. Study Identification

Unique Protocol Identification Number
NCT02805049
Brief Title
Pharmacokinetic Study on Echinocandins for Patients With Septic Shock Following Secondary Peritonitis
Official Title
Pharmacokinetic Study on Echinocandins for Patients With Septic Shock Following Secondary Peritonitis
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
January 28, 2017 (Actual)
Primary Completion Date
June 23, 2018 (Actual)
Study Completion Date
June 23, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nīmes

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Septic Shock, Peritonitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
The study population
Arm Type
Experimental
Arm Description
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).
Intervention Type
Drug
Intervention Name(s)
Echinocandins
Other Intervention Name(s)
caspofungin or micafungin
Intervention Description
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.
Primary Outcome Measure Information:
Title
Antifungal treatment plasmatic clearance (L/h)
Time Frame
Day 1
Title
Antifungal treatment plasmatic clearance (L/h)
Time Frame
Days 3-5
Title
The volume of distribution (L) corresponding to plasmatic antifungal treatment concentration
Time Frame
Day 1
Title
The volume of distribution (L) corresponding to plasmatic antifungal treatment concentration
Time Frame
Days 3-5
Title
Intercompartmental transfer constant for a bi-compartmental model for plasmatic antifungal treatment concentration
Time Frame
Day 1
Title
Intercompartmental transfer constant for a bi-compartmental model for plasmatic antifungal treatment concentration
Time Frame
Days 3-5
Title
The area under the curve for plasmatic antifungal treatment concentrations
Time Frame
Day 1
Title
The area under the curve for plasmatic antifungal treatment concentrations
Time Frame
Days 3-5
Title
The maximum concentration for plasmatic antifungal treatment concentrations
Time Frame
Day 1
Title
The maximum concentration for plasmatic antifungal treatment concentrations
Time Frame
Days 3-5
Title
The minimum concentration for plasmatic antifungal treatment concentrations
Time Frame
Day 1
Title
The minimum concentration for plasmatic antifungal treatment concentrations
Time Frame
Days 3-5
Secondary Outcome Measure Information:
Title
The target Pharmacokinetic/Pharmacodynamic ratio for caspofungin
Description
corresponds to: area under the curve / minimum inhibitory concentration >865
Time Frame
Day 1
Title
The target Pharmacokinetic/Pharmacodynamic ratio for caspofungin
Description
corresponds to: area under the curve / minimum inhibitory concentration >865
Time Frame
Days 3-5
Title
The target Pharmacokinetic/Pharmacodynamic ratio for micafungin
Description
corresponds to: area under the curve / minimum inhibitory concentration >285 et 3000
Time Frame
Day 1
Title
The target Pharmacokinetic/Pharmacodynamic ratio for micafungin
Description
corresponds to: area under the curve / minimum inhibitory concentration >285 et 3000
Time Frame
Days 3-5
Title
The area under the curve for peritoneal antifungal treatment concentrations
Time Frame
Day 1
Title
The area under the curve for peritoneal antifungal treatment concentrations
Time Frame
Days 3-5
Title
The maximum concentration for peritoneal antifungal treatment concentrations
Time Frame
Day 1
Title
The maximum concentration for peritoneal antifungal treatment concentrations
Time Frame
Days 3-5
Title
The minimum concentration for peritoneal antifungal treatment concentrations
Time Frame
Day 1
Title
The minimum concentration for peritoneal antifungal treatment concentrations
Time Frame
Days 3-5
Title
The probability of attaining the targeted Pharmacokinetic/Pharmacodynamic ratio
Time Frame
Day 1
Title
The probability of attaining the targeted Pharmacokinetic/Pharmacodynamic ratio
Time Frame
Days 3-5
Title
The fraction of the probability of attaining the targeted Pharmacokinetic/Pharmacodynamic ratio
Time Frame
Day 1
Title
The fraction of the probability of attaining the targeted Pharmacokinetic/Pharmacodynamic ratio
Time Frame
Days 3-5

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Claire Roger, MD
Organizational Affiliation
Centre Hospitalier Universitaire de Nîmes
Official's Role
Principal Investigator
Facility Information:
Facility Name
Royal Brisbane Women's Hospital
City
Herston
ZIP/Postal Code
4029
Country
Australia
Facility Name
CHU de Nîmes - Hôpital Universitaire Carémeau
City
Nîmes Cedex 09
ZIP/Postal Code
30029
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
26903338
Citation
Singer M, Deutschman CS, Seymour CW, Shankar-Hari M, Annane D, Bauer M, Bellomo R, Bernard GR, Chiche JD, Coopersmith CM, Hotchkiss RS, Levy MM, Marshall JC, Martin GS, Opal SM, Rubenfeld GD, van der Poll T, Vincent JL, Angus DC. The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3). JAMA. 2016 Feb 23;315(8):801-10. doi: 10.1001/jama.2016.0287.
Results Reference
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Pharmacokinetic Study on Echinocandins for Patients With Septic Shock Following Secondary Peritonitis

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