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

Sun Yat-sen University

Status

Unknown

Conditions

Invasive Fungal Infection

Treatments

Drug: Caspofungin

Study type

Interventional

Funder types

Other

Identifiers

NCT02510053

14030310568

Details and patient eligibility

About

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.

Enrollment

40 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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