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

Invasive Fungal Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02510053
• Other study ID #: 14030310568
• Status: Enrolling by invitation
• Phase: N/A
• First received: July 19, 2015
• Last updated: July 26, 2015
• Start date: July 2014

Study information

• Verified date: July 2015
• Source: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Chinese Medical Association
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 40
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Infection
• Invasive Fungal Infection
• Mycoses

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Peak Plasma Concentration (Cmax)		day 4	No
Primary	Area under the plasma concentration versus time curve (AUC)		day 4	No
Secondary	Drug-related adverse events		End of caspofungin treatment,an expected average of 20 days	Yes