NCT02805049

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Centre Hospitalier Universitaire de Nīmes · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Septic Shock
• Peritonitis

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2017-01-28
• Primary completion: 2018-06-18
• Completion: 2018-06-18
• First posted: 2016-06-17
• Last updated: 2025-12-10

Locations

2 sites across 2 countries: Australia, France