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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02510053

Enrollment

Registered

2015-07-28

Start date

2014-07-31

Completion date

Unknown

Last updated

2015-07-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Invasive Fungal Infection

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.

Interventions

DRUGCaspofungin

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

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

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

Secondary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026