Pharmacokinetics of Caspofungin (Cancidas ®) Given Intravenously as Therapy to Patients With an Invasive Fungal Infection in the Intensive Care Unit - a Search for Co-variates

Invasive Fungal Infection Clinical Trial

— CASCADE  

Official title:

Pharmacokinetics of Caspofungin (Cancidas ®) Given Intravenously as Therapy to Patients With an Invasive Fungal Infection in the Intensive Care Unit - a Search for Co-variates

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01533558
• Other study ID #: AKF UMCN 11.02
• Status: Completed
• Start date: January 2012
• Est. completion date: June 2013

Study information

• Verified date: November 2020
• Source: Radboud University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The pharmacokinetics of caspofungin are expected to be different in ICU patients compared to non-ICU patients. The investigators will determine caspofungin concentrations in 20 ICU patients, who will get caspofungin as standard care. Full PK curves will be taken on day 3 and a limited PK curve on day 7, trough levels will be taken daily.

Description:

The pharmacokinetics of caspofungin are expected to be different in ICU patients compared to non-ICU patients and healthy volunteers due to underlying disease(s). Therefore, extrapolation of data from healthy volunteers and non-ICU patients is not possible. To be able to include 20 patients within the study duration, a multi-centre approach is necessary. Patients will receive standard care, as stated in the SPC or according to local protocols. Blood sampling for PK analysis will be retrieved through a central venous catheter. Approximately 60mL will be drawn in total for this study. Patients will be monitored daily during the treatment period for adverse events of the study drug. Although steady state of caspofungin will be achieved after approximately 14 days of treatment, full PK curves will be taken on day 3. As probably not all patients included will be treated with caspofungin for 14 days, taking full PK curves on day 14 is considered not feasible. These two moments of PK analysis will enable the determination steady state and enable the determination of intra-individual variability.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: June 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patient is admitted to an ICU
• Subject is at least 18 and not older than 65 years of age on the day of the first dosing
• Subject has been treated with caspofungin for a maximum of two days before enrolment in this trial
• Is managed with a central venous catheter

Exclusion Criteria:

• Is known to be hypersensitive to echinocandin antifungal agents
• Documented history of sensitivity to medicinal products or excipients similar to those found in the caspofungin preparation
• Positive HIV test or hepatitis B or C test
• History of QT time prolongation
• History of or current abuse of drugs, alcohol or solvents
• Has previously participated in this trial

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Invasive Fungal Infection
• Invasive Fungal Infections
• Mycoses

Intervention

Drug:
• caspofungin
normal dosage for caspofungin, not adapted for the study

Locations

Country	Name	City	State
Netherlands	Rijnstate Hospital	Arnhem
Netherlands	Canisius Wilhelmina Hospital (CWZ)	Nijmegen
Netherlands	Radboud University Nijmegen Medical Centre	Nijmegen
Netherlands	University Medical Centre Utrecht	Utrecht

Sponsors (1)

Lead Sponsor	Collaborator
Radboud University

Country where clinical trial is conducted

Netherlands, 

References & Publications (1)

Muilwijk EW, Schouten JA, van Leeuwen HJ, van Zanten AR, de Lange DW, Colbers A, Verweij PE, Burger DM, Pickkers P, Brüggemann RJ. Pharmacokinetics of caspofungin in ICU patients. J Antimicrob Chemother. 2014 Dec;69(12):3294-9. doi: 10.1093/jac/dku313. Ep — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area Under Curve (AUC)	AUC0-tau, AUC0-inf (Time Frame: predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 20 and 24 hours post-dose on Day 3 and predose, 1, 4, 8, 12 hours + 6 days after the dose on Day 7) of caspofungin	day 3 and day 7
Secondary	co-variates influencing PK of caspofungin	identify co-variates of influence on the pharmacokinetics of caspofungin	day 3 and day 7
Secondary	Number of Participants with Adverse Events	the adverse events will be recorded in IC patients during the study	14 days