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

Not Applicable

• Conditions: Invasive Fungal Infection
• Interventions: Drug: Caspofungin

• Registration Number: NCT02510053
• Lead Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-07
• Status Verified: 2015-07
• Study First Submitted: 2015-07-19
• Study First Submitted QC: 2015-07-26
• Last Update Submitted: 2015-07-26
• Study First Posted: 2015-07-28
• Last Update Posted: 2015-07-28
• Primary Completion: 2016-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients With IFI in ICU	Caspofungin	40 patients receive Caspofungin for an Invasive Fungal Infection(IFI) in the Intensive Car will be recruited

Primary Outcome Measures

Name	Time	Method
Peak Plasma Concentration (Cmax)	day 4
Area under the plasma concentration versus time curve (AUC)	day 4

Secondary Outcome Measures

Name	Time	Method
Drug-related adverse events	End of caspofungin treatment,an expected average of 20 days