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

NCT02805049 | Completed Phase 4

• 2 other identifiers: LOCAL/2016/CR-012016-002708-17
• Study Type: interventional
• Target: 24
• Locations: 2 countries
• Sites: 2

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.

Conditions

Septic Shock; Peritonitis

Outcome Measures

Primary Outcomes (12)

• Antifungal treatment plasmatic clearance (L/h)

  Day 1

• Antifungal treatment plasmatic clearance (L/h)

  Days 3-5

• The volume of distribution (L) corresponding to plasmatic antifungal treatment concentration

  Day 1

• The volume of distribution (L) corresponding to plasmatic antifungal treatment concentration

  Days 3-5

• Intercompartmental transfer constant for a bi-compartmental model for plasmatic antifungal treatment concentration

  Day 1

• Intercompartmental transfer constant for a bi-compartmental model for plasmatic antifungal treatment concentration

  Days 3-5

• The area under the curve for plasmatic antifungal treatment concentrations

  Day 1

• The area under the curve for plasmatic antifungal treatment concentrations

  Days 3-5

• The maximum concentration for plasmatic antifungal treatment concentrations

  Day 1

• The maximum concentration for plasmatic antifungal treatment concentrations

  Days 3-5

• The minimum concentration for plasmatic antifungal treatment concentrations

  Day 1

• The minimum concentration for plasmatic antifungal treatment concentrations

  Days 3-5

Secondary Outcomes (14)

• The target Pharmacokinetic/Pharmacodynamic ratio for caspofungin

  Day 1

• The target Pharmacokinetic/Pharmacodynamic ratio for caspofungin

  Days 3-5

• The target Pharmacokinetic/Pharmacodynamic ratio for micafungin

  Day 1

• The target Pharmacokinetic/Pharmacodynamic ratio for micafungin

  Days 3-5

• The area under the curve for peritoneal antifungal treatment concentrations

  Day 1

Study Arms (1)

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).

Drug: Echinocandins

Interventions

Echinocandins DRUG

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

The study population

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

Study Sites (2)

Royal Brisbane Women's Hospital

Herston, 4029, Australia

Location

CHU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, 30029, France

Location

Related Publications (1)

• 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.

  PMID: 33846133 RESULT

MeSH Terms

Conditions

Shock, Septic; Peritonitis

Interventions

Echinocandins; Caspofungin; Micafungin

Condition Hierarchy (Ancestors)

Sepsis; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock; Intraabdominal Infections; Peritoneal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Peptides, Cyclic; Peptides; Amino Acids, Peptides, and Proteins; Lipopeptides; Lipids

Study Officials

• Claire Roger, MD

  Centre Hospitalier Universitaire de Nîmes

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2016
• First Posted: June 17, 2016
• Study Start: January 28, 2017
• Primary Completion: June 18, 2018
• Study Completion: June 18, 2018
• Last Updated: December 10, 2025

Record last verified: 2019-01

Locations

FR (1); AU (1)