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

NCT02510053 | Unknown

• 1 other identifier: 14030310568
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Invasive Fungal Infection

Outcome Measures

Primary Outcomes (2)

• Peak Plasma Concentration (Cmax)

  day 4

• Area under the plasma concentration versus time curve (AUC)

  day 4

Secondary Outcomes (1)

• Drug-related adverse events

  End of caspofungin treatment,an expected average of 20 days

Study Arms (1)

Patients With IFI in ICU

OTHER

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

Drug: Caspofungin

Interventions

Caspofungin DRUG

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

Also known as: Cancidas ®

Patients With IFI in ICU

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

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

MeSH Terms

Conditions

Invasive Fungal Infections

Interventions

Caspofungin

Condition Hierarchy (Ancestors)

Mycoses; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Lipopeptides; Lipids; Peptides; Amino Acids, Peptides, and Proteins; Echinocandins; Peptides, Cyclic

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: director,clinical research

Study Record Dates

• First Submitted: July 19, 2015
• First Posted: July 28, 2015
• Study Start: July 1, 2014
• Primary Completion: June 1, 2016
• Last Updated: July 28, 2015

Record last verified: 2015-07