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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:
ClinicalTrials.gov Identifier:
NCT01533558
First Posted: February 15, 2012
Last Update Posted: August 29, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Radboud University
January 19, 2012
February 15, 2012
August 29, 2013
January 2012
May 2013   (Final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01533558 on ClinicalTrials.gov Archive Site
  • co-variates influencing PK of caspofungin [ Time Frame: day 3 and day 7 ]
    identify co-variates of influence on the pharmacokinetics of caspofungin
  • Number of Participants with Adverse Events [ Time Frame: 14 days ]
    the adverse events will be recorded in IC patients during the study
Same as current
Not Provided
Not Provided
 
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
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

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.

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.

Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:
Plasma samples for determination of caspofungin
Probability Sample
intensive care patients with invasive fungal infection
Invasive Fungal Infection
Drug: caspofungin
normal dosage for caspofungin, not adapted for the study
Other Name: Cancidas
caspofungin
caspofungin dosing
Intervention: Drug: caspofungin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
June 2013
May 2013   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
 
NCT01533558
AKF UMCN 11.02
No
Not Provided
Not Provided
Radboud University
Radboud University
Not Provided
Principal Investigator: Roger Brüggemann, PhD, PharmD Radboud University
Radboud University
August 2013