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Study of the pharmacokinetics and optimal dosage of caspofungin in intensive care patients with a suspected fungal infection.

Pharmacokinetics and optimal dosage of caspofungin in critically ill patients with suspected invasive candidiasis. - Optimal dosage of caspofungin in critically ill.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2012-003617-34-NL
Enrollment
Unknown
Registered
2012-11-08
Start date
2013-01-30
Completion date
Unknown
Last updated
2015-12-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

suspected invasive candidiasis

Interventions

Trade Name: Cancidas Product Name: Cancidas Product Code: J02AX04 Pharmaceutical Form: Powder for solution for infusion

Sponsors

University Medical Center Groningen
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Treatment with caspofungin. Admission to an ICU. Age = 18 years. Suspected invasive candidiasis. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 40 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 40

Exclusion criteria

Exclusion criteria: Blood sampling not possible.

Design outcomes

Primary

MeasureTime frame
Main Objective: Determine the pharmacokinetics of caspofungin, and the optimal dosage of caspofungin at which an adequate exposure is achieved in critically ill patients.;Secondary Objective: 1) Pharmacokinetic parameters of caspofungin in critically ill patients. 2) Correlation of pharmacokinetic parameters and the plasma concentration of caspofungin with disease severity scores. 3) Correlation of the plasma concentration of caspofungin with candida eradication. 4) Correlation of the plasma concentration of caspofungin with inflammation parameters. 5) AUC/MIC ratio and Cmax/MIC ratio. 6) Constructing a pharmacokinetic model of caspofungin in critically ill patients. 7) Drug-related adverse events of caspofungin. 8) The amount of caspofungin that is lost in dialysis.;Primary end point(s): The exposure to caspofungin, an AUC of 98 mg*h/L is established as an adequate exposure;Timepoint(s) of evaluation of this end point: Day 3 (± 1 day) of treatment with caspofungin.—

Secondary

MeasureTime frame
Secondary end point(s): 1) Pharmacokinetic parameters of caspofungin in critically ill patients. 2) Correlation of pharmacokinetic parameters and the plasma concentration of caspofungin with disease severity scores. 3) Correlation of the plasma concentration of caspofungin with candida eradication. 4) Correlation of the plasma concentration of caspofungin with inflammation parameters. 5) AUC/MIC ratio and Cmax/MIC ratio. 6) Constructing a pharmacokinetic model of caspofungin in critically ill patients. 7) Drug-related adverse events of caspofungin. 8) The amount of caspofungin that is lost in dialysis.;Timepoint(s) of evaluation of this end point: 1) day 3. 2) day 3. 3) day 28. 4) day 3. 5) day 28. 6) day 28. 7) day 28. 8) day 28.—

Countries

Netherlands

Contacts

Public ContactJ.G.W. Kosterink

University Medical Center Groningen

j.g.w.kosterink@umcg.nl+31503614070

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026