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

Sponsor
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University (Other)
Overall Status
Unknown status
CT.gov ID
NCT02510053
Collaborator
(none)
40
1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
PK-PD of Caspofungin (Cancidas ®) and Drug Tolerance of Fungi to Patients With an Invasive Fungal Infection in the Intensive Care Unit
Study Start Date :
Jul 1, 2014
Anticipated Primary Completion Date :
Jun 1, 2016

Arms and Interventions

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 ®
  • Outcome Measures

    Primary Outcome Measures

    1. Peak Plasma Concentration (Cmax) [day 4]

    2. Area under the plasma concentration versus time curve (AUC) [day 4]

    Secondary Outcome Measures

    1. Drug-related adverse events [End of caspofungin treatment,an expected average of 20 days]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

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

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Zhi-jie He, director,clinical research, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
    ClinicalTrials.gov Identifier:
    NCT02510053
    Other Study ID Numbers:
    • 14030310568
    First Posted:
    Jul 28, 2015
    Last Update Posted:
    Jul 28, 2015
    Last Verified:
    Jul 1, 2015

    Study Results

    No Results Posted as of Jul 28, 2015