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

Information source: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Invasive Fungal Infection

Intervention: Caspofungin (Drug)

Phase: N/A

Status: Enrolling by invitation

Sponsored by: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

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.

Clinical Details

Official title: PK-PD of Caspofungin (Cancidas ) and Drug Tolerance of Fungi to Patients With an Invasive Fungal Infection in the Intensive Care Unit

Study design: Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Peak Plasma Concentration (Cmax)

Area under the plasma concentration versus time curve (AUC)

Secondary outcome: Drug-related adverse events

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Patient is admitted to ICU with APACHE-II score more than 15

- Subject is 18 years old and older on the day of the first dosing

- Subject with evidence of proven or probable IFI defined by modified criteria of

European Organization for Research and Treatment of Cancer(EORTC) Exclusion Criteria:

- patient is known to be hypersensitive to caspofungin

- patient's Child-Pugh score is more than 9

- patient is prone to discontinue treatment result from lack of cost

- patient or their guardian refuse to sign a informed consent form

- patient concurrently receiving efavirenz, nevirapine, rifampin, systemic

dexamethasone, phenytoin, carbamazepine, phenobarbital, or cyclosporine and other agents have influence on PK parameters of caspofungin

- patient is treated with caspofungin within 24 hours

Locations and Contacts

Additional Information

Starting date: July 2014
Last updated: July 26, 2015

Page last updated: August 20, 2015

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