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OpenTrials
Completed

NCT Number: NCT02596984

Evaluation of the Pharmacokinetics of Caspofungin in ICU Patients

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de CLERMONT-FERRAND, Clermont-Ferrand, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Caspofungin

Drug

Either preemptive, empirical or curative prescription of Caspofungin by one of the ICUs' attending physician. Caspofungin will be administered according to the international recommendation

Primary outcomes

  1. Caspofungin pharmacokinetic : clearance (ml.min-1)

    Time frame: day 2 - day 3 - day 4

  2. Caspofungin pharmacokinetic : volume of distribution (mL)

    Time frame: day 2 - day 3 - day 4

Secondary outcomes

  1. Caspofungin trough concentration

    Time frame: day 2 - day 3 - day 4

  2. proportion of patients for whom the trough concentrations are lower than the MIC (Minimum Inhibitory Concentration) 90 of Candida ( 1mg / L)

    Time frame: day 2 - day 3 - day 4

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne

Other

Collaborators

  • Merck Sharp & Dohme LLC

Registry information

Acronym: CaspoKin

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Nov 4, 2015
Registry last updated
Jun 14, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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