- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01994096
Optimal Dosage of Caspofungin in Critically Ill Patients
Pharmacokinetics and Optimal Dosage of Caspofungin in Critically Ill Patients With Suspected Invasive Candidiasis
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
-
Groningen, Netherlands, 9700 RB
- University Medical Centre Groningen
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Caspofungin
1 arm, dose adjustment of caspofungin when exposure is inadequate
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The optimal dosage of caspofungin in relation to adequate exposure (measured as AUC) in critically ill patients.
Time Frame: 7 days
|
7 days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Pharmacokinetic parameters of caspofungin in critically ill patients.
Time Frame: 3 days
|
3 days
|
Correlation of pharmacokinetic parameters and the plasma concentration of caspofungin with disease severity scores.
Time Frame: 3 days
|
3 days
|
Correlation of the plasma concentration of caspofungin with candida eradication.
Time Frame: 28 days
|
28 days
|
Correlation of the plasma concentration of caspofungin with inflammation parameters.
Time Frame: 3 days
|
3 days
|
AUC/MIC ratio and highest observed plasma concentration (Cmax)/MIC ratio.
Time Frame: 7 days
|
7 days
|
Constructing a pharmacokinetic model of caspofungin in critically ill patients.
Time Frame: 28 days
|
28 days
|
Drug-related adverse events of caspofungin.
Time Frame: 28 days
|
28 days
|
Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NL41676.042.12
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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