Status:

COMPLETED

Pharmacokinetics/Pharmacodynamics (PK/PD) of Caspofungin in Intensive Care Unit (ICU) Patients. An Open Observational Study for Antifungal Treatment's Optimization

Lead Sponsor:

Careggi Hospital

Conditions:

Critical Illness

Infection

Eligibility:

All Genders

Brief Summary

PK of Caspofungin in ICU septic patients might be changed as compared to healthy volunteers due to sepsis-related pathophysiology. Sub-optimal plasma and tissue concentrations might be achieved in th...

Detailed Description

Open non randomized, non controlled single center study on the pharmacokinetics of caspofungin in 20 consecutive ICU patients with severe sepsis or septic shock, requiring caspofungin therapy and PK-P...

Eligibility Criteria

Inclusion

  • Adult ICU patients (\>18 yrs)
  • Severe sepsis or septic shock
  • Caspofungin therapy based on clinical judgement (empiric therapy) or microbiological result (targeted therapy).

Exclusion

  • Concomitant ciclosporin or rifampicin therapy.
  • Pregnancy
  • Continuous renal replacement therapy
  • Severe Liver failure (Child Pugh score \> 6)

Key Trial Info

Start Date :

January 1 2016

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

December 31 2018

Estimated Enrollment :

20 Patients enrolled

Trial Details

Trial ID

NCT03798600

Start Date

January 1 2016

End Date

December 31 2018

Last Update

January 17 2019

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