Evaluation of the Pharmacokinetics of Caspofungin in ICU Patients

Not Applicable

Completed

• Conditions: Shock
• Interventions: Drug: Caspofungin

• Registration Number: NCT02596984
• Lead Sponsor: Centre Hospitalier Universitaire de Saint Etienne

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-03-16
• Study First Submitted: 2015-11-03
• Study First Submitted QC: 2015-11-03
• Study First Posted: 2015-11-04
• Primary Completion: 2018-05
• Study Completion: 2018-05-31
• Status Verified: 2019-06
• Last Update Submitted: 2019-06-12
• Last Update Posted: 2019-06-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
caspofungin	Caspofungin	Caspofungin will be administered according to the international recommendation.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (3)

CHU de CLERMONT-FERRAND; 🇫🇷 Clermont-ferrand, France

Hôpital Saint-Louis; 🇫🇷 Paris, France

CHU de SAINT-ETIENNE; 🇫🇷 Saint-etienne, France