Evaluation of the Pharmacokinetics of Caspofungin in ICU Patients

Study Overview
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Brief Summary
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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.

Official Title
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Evaluation of the Pharmacokinetics of Caspofungin in ICU Patients

Conditions
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Shock

Intervention / Treatment
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* Drug: Caspofungin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: caspofungin<br>Caspofungin will be administered according to the international recommendation. | Drug: Caspofungin<br>* Either preemptive, empirical or curative prescription of Caspofungin by one of the ICUs' attending physician. Caspofungin will be administered according to the international recommendation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Intensive Care Unit, Shock, Antifungal agent, Pharmacokinetics, Sepsis