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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-07-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Invasive Fungal Infection

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Patients With IFI in ICU

40 patients receive Caspofungin for an Invasive Fungal Infection(IFI) in the Intensive Car will be recruited

Group Type OTHER

Caspofungin

Intervention Type DRUG

40 patients with suspected/preoperation/confirmed IFI in ICU received Caspofungin

Interventions

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Caspofungin

40 patients with suspected/preoperation/confirmed IFI in ICU received Caspofungin

Intervention Type DRUG

Other Intervention Names

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Cancidas ®

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No