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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 (CASCADE)

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ClinicalTrials.gov Identifier: NCT01533558
Recruitment Status : Completed
First Posted : February 15, 2012
Last Update Posted : August 29, 2013
Sponsor:
Information provided by (Responsible Party):
Radboud University

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
Invasive Fungal Infection Drug: caspofungin

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 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 : January 2012
Actual Primary Completion Date : May 2013
Actual Study Completion Date : June 2013

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
caspofungin
caspofungin dosing
Drug: caspofungin
normal dosage for caspofungin, not adapted for the study
Other Name: Cancidas




Primary Outcome Measures :
  1. Area Under Curve (AUC) [ Time Frame: 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 [ Time Frame: day 3 and day 7 ]
    identify co-variates of influence on the pharmacokinetics of caspofungin

  2. Number of Participants with Adverse Events [ Time Frame: 14 days ]
    the adverse events will be recorded in IC patients during the study


Biospecimen Retention:   Samples Without DNA
Plasma samples for determination of caspofungin


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
intensive care patients with invasive fungal infection
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01533558


Locations
Netherlands
Rijnstate Hospital
Arnhem, Netherlands
Canisius Wilhelmina Hospital (CWZ)
Nijmegen, Netherlands
Radboud University Nijmegen Medical Centre
Nijmegen, Netherlands
University Medical Centre Utrecht
Utrecht, Netherlands
Sponsors and Collaborators
Radboud University
Investigators
Principal Investigator: Roger Brüggemann, PhD, PharmD Radboud University

Responsible Party: Radboud University
ClinicalTrials.gov Identifier: NCT01533558     History of Changes
Other Study ID Numbers: AKF UMCN 11.02
First Posted: February 15, 2012    Key Record Dates
Last Update Posted: August 29, 2013
Last Verified: August 2013

Keywords provided by Radboud University:
caspofungin
pharmacokinetics
invasive fungal infection
candidiasis
aspergillosis
intensive care

Additional relevant MeSH terms:
Infection
Communicable Diseases
Mycoses
Invasive Fungal Infections
Caspofungin
Echinocandins
Antifungal Agents
Anti-Infective Agents