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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)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Radboud University
ClinicalTrials.gov Identifier:
NCT01533558
First received: January 19, 2012
Last updated: August 28, 2013
Last verified: August 2013
  Purpose

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 Intervention
Invasive Fungal Infection
Drug: caspofungin

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Radboud University:

Primary Outcome Measures:
  • Area Under Curve (AUC) [ Time Frame: day 3 and day 7 ] [ Designated as safety issue: No ]
    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:
  • co-variates influencing PK of caspofungin [ Time Frame: day 3 and day 7 ] [ Designated as safety issue: No ]
    identify co-variates of influence on the pharmacokinetics of caspofungin

  • Number of Participants with Adverse Events [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]
    the adverse events will be recorded in IC patients during the study


Biospecimen Retention:   Samples Without DNA

Plasma samples for determination of caspofungin


Enrollment: 20
Study Start Date: January 2012
Study Completion Date: June 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
caspofungin
caspofungin dosing
Drug: caspofungin
normal dosage for caspofungin, not adapted for the study
Other Name: Cancidas

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Radboud University
ClinicalTrials.gov Identifier: NCT01533558     History of Changes
Other Study ID Numbers: AKF UMCN 11.02
Study First Received: January 19, 2012
Last Updated: August 28, 2013
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

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

Additional relevant MeSH terms:
Communicable Diseases
Infection
Mycoses
Caspofungin
Echinocandins
Anti-Infective Agents
Antifungal Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014