Evaluation of the Pharmacokinetics of Caspofungin in ICU Patients (CaspoKin)

Although the pharmacokinetics of Caspofungin has been studied in healthy subjects and patients, only a few studies have been performed in critically-ill patients. In these patients several factors, including sepsis, shock, increased distribution volume, hepatic dysfunction and hypoalbuminemia may result in dramatic changes in antibiotic concentrations and pharmacokinetics. Caspofungin pharmacokinetic data is scarce and are results mainly from case series or animal studies. Thus, studies performed so far show Caspofungin trough concentrations either decreased, similar to usual value in non-critically ill patients or increased. One of these studies suggested that body weight and hypoalbuminemia may be the main factors associated with Caspofungin pharmacokinetic variability. Pharmacokinetic parameters of caspofungin in pigs with hypovolemic shock suggested the peripheral volume of distribution of caspofungin and intercompartmental clearance to be higher than in healthy animals. These results are however preliminary and cannot be extrapolated suggesting further clinical studies in human to be needed.

The primary objective of this study is to assess Caspofungin trough concentrations and pharmacokinetics in critically-ill patients requiring vasopressors.

Study Overview

• Status: Completed
• Conditions: Shock
• Intervention / Treatment: Drug: Caspofungin

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Clermont-ferrand, France, 63000
    • CHU de Clermont-Ferrand
  • Paris, France, 75010
    • Hôpital Saint-Louis
  • Saint-etienne, France, 42000
    • CHU de Saint-Etienne

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Adult patients (age > 18 y.o)
• Either preemptive, empirical or curative prescription of Caspofungin by one of the ICUs' attending physician
• Requiring vasopressors
• Admission in one of the participating ICUs.

Exclusion Criteria:

• Pregnancy
• Lack of affiliation to the National Medical Insurance
• Previous inclusion in the study
• Inclusion in a concomitant study that may interact with the current study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: caspofungin; Caspofungin will be administered according to the international recommendation.	Drug: Caspofungin; Either preemptive, empirical or curative prescription of Caspofungin by one of the ICUs' attending physician. Caspofungin will be administered according to the international recommendation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Caspofungin pharmacokinetic : clearance (ml.min-1)	day 2 - day 3 - day 4
Caspofungin pharmacokinetic : volume of distribution (mL)	day 2 - day 3 - day 4

Secondary Outcome Measures

Outcome Measure	Time Frame
Caspofungin trough concentration	day 2 - day 3 - day 4
proportion of patients for whom the trough concentrations are lower than the MIC (Minimum Inhibitory Concentration) 90 of Candida ( 1mg / L)	day 2 - day 3 - day 4

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Saint Etienne
• Collaborators: Merck Sharp & Dohme LLC

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 16, 2015
• Primary Completion (ACTUAL): May 1, 2018
• Study Completion (ACTUAL): May 31, 2018

Study Registration Dates

• First Submitted: November 3, 2015
• First Submitted That Met QC Criteria: November 3, 2015
• First Posted (ESTIMATE): November 4, 2015

Study Record Updates

• Last Update Posted (ACTUAL): June 14, 2019
• Last Update Submitted That Met QC Criteria: June 12, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Keywords: Shock; Pharmacokinetics; Intensive Care Unit; Sepsis; Antifungal agent
• Additional Relevant MeSH Terms: Pathologic Processes; Shock; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antifungal Agents; Caspofungin
• Other Study ID Numbers: 1308173; 140413A-41 (OTHER: ANSM); 2014-000789-22 (EUDRACT_NUMBER)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No