CaspoKin: Evaluation of the Pharmacokinetics of Caspofungin in ICU Patients

Sponsor

Centre Hospitalier Universitaire de Saint Etienne (Other)

Overall Status

Completed

CT.gov ID

NCT02596984

Collaborator

Merck Sharp & Dohme LLC (Industry)

Enrollment

Locations

Arm

38.5

Actual Duration (Months)

16.7

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Shock	Drug: Caspofungin	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

50 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Evaluation of the Pharmacokinetics of Caspofungin in ICU Patients

Actual Study Start Date :

Mar 16, 2015

Actual Primary Completion Date :

May 1, 2018

Actual Study Completion Date :

May 31, 2018

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.