Back to resultsOptimal Dosage of Caspofungin in Critically Ill Patients
Primary Purpose
Critically Ill, Suspected Invasive Candidiasis
Status
Completed
Phase
Phase 4
Locations
Netherlands
Study Type
Interventional
Intervention
Caspofungin
Sponsored by
About this trial
This is an interventional treatment trial for Critically Ill
Eligibility Criteria
Inclusion Criteria:
- Treatment with caspofungin.
- Admission to an ICU.
- Age ≥ 18 years.
- Suspected invasive candidiasis, established by the physician.
Exclusion Criteria:
- Blood sampling by central venous catheter or peripheral cannula not possible.
Sites / Locations
- University Medical Centre Groningen
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Caspofungin
Arm Description
1 arm, dose adjustment of caspofungin when exposure is inadequate
Outcomes
Primary Outcome Measures
The optimal dosage of caspofungin in relation to adequate exposure (measured as AUC) in critically ill patients.
Secondary Outcome Measures
Pharmacokinetic parameters of caspofungin in critically ill patients.
Correlation of pharmacokinetic parameters and the plasma concentration of caspofungin with disease severity scores.
Correlation of the plasma concentration of caspofungin with candida eradication.
Correlation of the plasma concentration of caspofungin with inflammation parameters.
AUC/MIC ratio and highest observed plasma concentration (Cmax)/MIC ratio.
Constructing a pharmacokinetic model of caspofungin in critically ill patients.
Drug-related adverse events of caspofungin.
Full Information
NCT ID
NCT01994096
First Posted
November 19, 2013
Last Updated
October 29, 2015
Sponsor
University Medical Center Groningen
1. Study Identification
Unique Protocol Identification Number
NCT01994096
Brief Title
Optimal Dosage of Caspofungin in Critically Ill Patients
Official Title
Pharmacokinetics and Optimal Dosage of Caspofungin in Critically Ill Patients With Suspected Invasive Candidiasis
Study Type
Interventional
2. Study Status
Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
November 2013 (undefined)
Primary Completion Date
October 2015 (Actual)
Study Completion Date
October 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Medical Center Groningen
4. Oversight
5. Study Description
Brief Summary
Intensive care unit (ICU) patients are especially at risk for invasive candidiasis due to the presence of risk factors. It is known that in critically ill patients, alterations in function of various organs and body systems can influence the pharmacokinetics and hence the plasma concentration of a drug. A study of caspofungin in ICU patients has found a high inter- and intra-individual variability in caspofungin concentration. Factors that caused subtherapeutic caspofungin plasma concentrations were body weight > 75 kg and hypoalbuminemia. Furthermore, an efficacy study showed a lower response rate for caspofungin among patients with a higher disease severity score.
As a result of the altered pharmacokinetics, under- or over-exposure of caspofungin can occur in critically ill patients and an adjusted dosage might be necessary in these patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Critically Ill, Suspected Invasive Candidiasis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Caspofungin
Arm Type
Experimental
Arm Description
1 arm, dose adjustment of caspofungin when exposure is inadequate
Intervention Type
Drug
Intervention Name(s)
Caspofungin
Primary Outcome Measure Information:
Title
The optimal dosage of caspofungin in relation to adequate exposure (measured as AUC) in critically ill patients.
Time Frame
7 days
Secondary Outcome Measure Information:
Title
Pharmacokinetic parameters of caspofungin in critically ill patients.
Time Frame
3 days
Title
Correlation of pharmacokinetic parameters and the plasma concentration of caspofungin with disease severity scores.
Time Frame
3 days
Title
Correlation of the plasma concentration of caspofungin with candida eradication.
Time Frame
28 days
Title
Correlation of the plasma concentration of caspofungin with inflammation parameters.
Time Frame
3 days
Title
AUC/MIC ratio and highest observed plasma concentration (Cmax)/MIC ratio.
Time Frame
7 days
Title
Constructing a pharmacokinetic model of caspofungin in critically ill patients.
Time Frame
28 days
Title
Drug-related adverse events of caspofungin.
Time Frame
28 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Treatment with caspofungin.
Admission to an ICU.
Age ≥ 18 years.
Suspected invasive candidiasis, established by the physician.
Exclusion Criteria:
Blood sampling by central venous catheter or peripheral cannula not possible.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jan-Willem Alffenaar, PharmD, PhD
Organizational Affiliation
University Medical Center Groningen
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Medical Centre Groningen
City
Groningen
ZIP/Postal Code
9700 RB
Country
Netherlands
12. IPD Sharing Statement
Citations:
PubMed Identifier
27855112
Citation
van der Elst KC, Veringa A, Zijlstra JG, Beishuizen A, Klont R, Brummelhuis-Visser P, Uges DR, Touw DJ, Kosterink JG, van der Werf TS, Alffenaar JC. Low Caspofungin Exposure in Patients in Intensive Care Units. Antimicrob Agents Chemother. 2017 Jan 24;61(2):e01582-16. doi: 10.1128/AAC.01582-16. Print 2017 Feb.
Results Reference
derived
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Optimal Dosage of Caspofungin in Critically Ill Patients
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