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

Completed

• Conditions: Invasive Fungal Infection
• Interventions: Drug: caspofungin

• Registration Number: NCT01533558
• Lead Sponsor: Radboud University Medical Center

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2012-01
• Study First Submitted: 2012-01-19
• Study First Submitted QC: 2012-02-10
• Study First Posted: 2012-02-15
• Primary Completion: 2013-05
• Study Completion: 2013-06
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-26
• Last Update Posted: 2020-12-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
caspofungin	caspofungin	caspofungin dosing

Primary Outcome Measures

Name	Time	Method
Area Under Curve (AUC)	day 3 and day 7	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

Secondary Outcome Measures

Name	Time	Method
co-variates influencing PK of caspofungin	day 3 and day 7	identify co-variates of influence on the pharmacokinetics of caspofungin
Number of Participants with Adverse Events	14 days	the adverse events will be recorded in IC patients during the study

Trial Locations

Locations (4)

Canisius Wilhelmina Hospital (CWZ); 🇳🇱 Nijmegen, Netherlands

Radboud University Nijmegen Medical Centre; 🇳🇱 Nijmegen, Netherlands

University Medical Centre Utrecht; 🇳🇱 Utrecht, Netherlands

Rijnstate Hospital; 🇳🇱 Arnhem, Netherlands