CASCADE: 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

Sponsor
Radboud University Medical Center (Other)
Overall Status
Completed
CT.gov ID
NCT01533558
Collaborator
(none)
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Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

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 Design

Study Type:
Observational
Actual Enrollment :
20 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
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
Study Start Date :
Jan 1, 2012
Actual Primary Completion Date :
May 1, 2013
Actual Study Completion Date :
Jun 1, 2013

Arms and Interventions

Arm Intervention/Treatment
caspofungin

caspofungin dosing

Drug: caspofungin
normal dosage for caspofungin, not adapted for the study
Other Names:
  • Cancidas
  • Outcome Measures

    Primary Outcome Measures

    1. 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

    1. co-variates influencing PK of caspofungin [day 3 and day 7]

      identify co-variates of influence on the pharmacokinetics of caspofungin

    2. Number of Participants with Adverse Events [14 days]

      the adverse events will be recorded in IC patients during the study

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Rijnstate Hospital Arnhem Netherlands
    2 Canisius Wilhelmina Hospital (CWZ) Nijmegen Netherlands
    3 Radboud University Nijmegen Medical Centre Nijmegen Netherlands
    4 University Medical Centre Utrecht Utrecht Netherlands

    Sponsors and Collaborators

    • Radboud University Medical Center

    Investigators

    • Principal Investigator: Roger Brüggemann, PhD, PharmD, Radboud University Medical Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Radboud University Medical Center
    ClinicalTrials.gov Identifier:
    NCT01533558
    Other Study ID Numbers:
    • AKF UMCN 11.02
    First Posted:
    Feb 15, 2012
    Last Update Posted:
    Dec 1, 2020
    Last Verified:
    Nov 1, 2020

    Study Results

    No Results Posted as of Dec 1, 2020