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

Septic Shock Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02805049
• Other study ID #: LOCAL/2016/CR-01
• Status: Completed
• Phase: Phase 4
• Start date: January 28, 2017
• Est. completion date: June 23, 2018

Study information

• Verified date: January 2019
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: June 23, 2018
• Est. primary completion date: June 23, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Peritonitis
• Septic Shock
• Shock
• Shock, Septic

Intervention

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.

Locations

Country	Name	City	State
Australia	Royal Brisbane Women's Hospital	Herston
France	CHU de Nîmes - Hôpital Universitaire Carémeau	Nîmes Cedex 09

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Countries where clinical trial is conducted

Australia,  France, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Antifungal treatment plasmatic clearance (L/h)		Day 1
Primary	Antifungal treatment plasmatic clearance (L/h)		Days 3-5
Primary	The volume of distribution (L) corresponding to plasmatic antifungal treatment concentration		Day 1
Primary	The volume of distribution (L) corresponding to plasmatic antifungal treatment concentration		Days 3-5
Primary	Intercompartmental transfer constant for a bi-compartmental model for plasmatic antifungal treatment concentration		Day 1
Primary	Intercompartmental transfer constant for a bi-compartmental model for plasmatic antifungal treatment concentration		Days 3-5
Primary	The area under the curve for plasmatic antifungal treatment concentrations		Day 1
Primary	The area under the curve for plasmatic antifungal treatment concentrations		Days 3-5
Primary	The maximum concentration for plasmatic antifungal treatment concentrations		Day 1
Primary	The maximum concentration for plasmatic antifungal treatment concentrations		Days 3-5
Primary	The minimum concentration for plasmatic antifungal treatment concentrations		Day 1
Primary	The minimum concentration for plasmatic antifungal treatment concentrations		Days 3-5
Secondary	The target Pharmacokinetic/Pharmacodynamic ratio for caspofungin	corresponds to: area under the curve / minimum inhibitory concentration >865	Day 1
Secondary	The target Pharmacokinetic/Pharmacodynamic ratio for caspofungin	corresponds to: area under the curve / minimum inhibitory concentration >865	Days 3-5
Secondary	The target Pharmacokinetic/Pharmacodynamic ratio for micafungin	corresponds to: area under the curve / minimum inhibitory concentration >285 et 3000	Day 1
Secondary	The target Pharmacokinetic/Pharmacodynamic ratio for micafungin	corresponds to: area under the curve / minimum inhibitory concentration >285 et 3000	Days 3-5
Secondary	The area under the curve for peritoneal antifungal treatment concentrations		Day 1
Secondary	The area under the curve for peritoneal antifungal treatment concentrations		Days 3-5
Secondary	The maximum concentration for peritoneal antifungal treatment concentrations		Day 1
Secondary	The maximum concentration for peritoneal antifungal treatment concentrations		Days 3-5
Secondary	The minimum concentration for peritoneal antifungal treatment concentrations		Day 1
Secondary	The minimum concentration for peritoneal antifungal treatment concentrations		Days 3-5
Secondary	The probability of attaining the targeted Pharmacokinetic/Pharmacodynamic ratio		Day 1
Secondary	The probability of attaining the targeted Pharmacokinetic/Pharmacodynamic ratio		Days 3-5
Secondary	The fraction of the probability of attaining the targeted Pharmacokinetic/Pharmacodynamic ratio		Day 1
Secondary	The fraction of the probability of attaining the targeted Pharmacokinetic/Pharmacodynamic ratio		Days 3-5