Evaluation of the Pharmacokinetics of Caspofungin in ICU Patients

Shock Clinical Trial

— CaspoKin  

Official title:

Evaluation of the Pharmacokinetics of Caspofungin in ICU Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02596984
• Other study ID #: 1308173
• Secondary ID: 140413A-412014-0
• Status: Completed
• Phase: N/A
• Start date: March 16, 2015
• Est. completion date: May 31, 2018

Study information

• Verified date: June 2019
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: May 31, 2018
• Est. primary completion date: May 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Shock

Intervention

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

Locations

Country	Name	City	State
France	CHU de CLERMONT-FERRAND	Clermont-ferrand
France	Hôpital Saint-Louis	Paris
France	CHU de SAINT-ETIENNE	Saint-etienne

Sponsors (2)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne	Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Caspofungin pharmacokinetic : clearance (ml.min-1)		day 2 - day 3 - day 4
Primary	Caspofungin pharmacokinetic : volume of distribution (mL)		day 2 - day 3 - day 4
Secondary	Caspofungin trough concentration		day 2 - day 3 - day 4
Secondary	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