drugset / Trial / NCT02510053

Pharmacokinetics and Pharmacodynamics of Caspofungin (Cancidas ®) and Drug Tolerance of Fungi to Patients With an Invasive Fungal Infection in the Intensive Care Unit

NCT02510053

Non-randomizedSingle-groupOpen-labelTreatment

Summary

To investigate pharmacokinetics(PK) and pharmacodynamics(PD) of Caspofungin in ICU patients after received a loading dose of 70mg followed by 50mg (35mg if Child-Pugh score is 7-9), 40 patients will be recruited. Blood samplings for PK analysis will be collected on day 4 in this study. Caspofungin plasma concentrations are measured by using solid phase extraction and reverse phase high-performance liquid chromatography. Safety analyses will be taken daily during the treatment of Caspofungin. Tests for drug tolerance of fungi and efficacy assessment (clinical and mycological responses) will be taken every 3 days by clinical and mycological tests.

Timeline

Start
2014-07
Primary completion
2016-06
Completion

Drugs

EvaluationDrugModalityDoseRoute
Subject Caspofungin Other / unclassified 35 mg
Subject Caspofungin Other / unclassified 50 mg