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

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

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.

Study Overview

• Status: Unknown
• Conditions: Invasive Fungal Infection
• Intervention / Treatment: Drug: Caspofungin

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Patients With IFI in ICU; 40 patients receive Caspofungin for an Invasive Fungal Infection(IFI) in the Intensive Car will be recruited	Drug: Caspofungin; 40 patients with suspected/preoperation/confirmed IFI in ICU received Caspofungin; Other Names: Cancidas ®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Peak Plasma Concentration (Cmax)	day 4
Area under the plasma concentration versus time curve (AUC)	day 4

Secondary Outcome Measures

Outcome Measure	Time Frame
Drug-related adverse events	End of caspofungin treatment,an expected average of 20 days

Collaborators and Investigators

• Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Study record dates

Study Major Dates

• Study Start: July 1, 2014
• Primary Completion (Anticipated): June 1, 2016

Study Registration Dates

• First Submitted: July 19, 2015
• First Submitted That Met QC Criteria: July 26, 2015
• First Posted (Estimate): July 28, 2015

Study Record Updates

• Last Update Posted (Estimate): July 28, 2015
• Last Update Submitted That Met QC Criteria: July 26, 2015
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Bacterial Infections and Mycoses; Infections; Communicable Diseases; Mycoses; Invasive Fungal Infections; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antifungal Agents; Caspofungin
• Other Study ID Numbers: 14030310568