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

Primary Purpose

Invasive Fungal Infection

Status

Unknown status

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Caspofungin

About this trial

This is an interventional treatment trial for Invasive Fungal Infection

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Patients With IFI in ICU

Arm Description

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

Outcomes

Primary Outcome Measures

Peak Plasma Concentration (Cmax)

Area under the plasma concentration versus time curve (AUC)

Secondary Outcome Measures

Drug-related adverse events

Full Information

NCT ID

NCT02510053

First Posted

July 19, 2015

Last Updated

July 26, 2015

Sponsor

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

1. Study Identification

Unique Protocol Identification Number

NCT02510053

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

July 2015

Overall Recruitment Status

Unknown status

Study Start Date

July 2014 (undefined)

Primary Completion Date

June 2016 (Anticipated)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

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

4. Oversight

Data Monitoring Committee

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Invasive Fungal Infection

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Patients With IFI in ICU

Arm Type

Other

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Caspofungin

Other Intervention Name(s)

Cancidas ®

Intervention Description

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

Primary Outcome Measure Information:

Title

Peak Plasma Concentration (Cmax)

Time Frame

day 4

Title

Area under the plasma concentration versus time curve (AUC)

Time Frame

day 4

Secondary Outcome Measure Information:

Title

Drug-related adverse events

Time Frame

End of caspofungin treatment,an expected average of 20 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

12. IPD Sharing Statement

Learn more about this trial

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

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