Optimal Dosage of Caspofungin in Critically Ill Patients

This study has been completed.
Information provided by (Responsible Party):
JWC Alffenaar, University Medical Center Groningen
ClinicalTrials.gov Identifier:
First received: November 19, 2013
Last updated: October 29, 2015
Last verified: October 2015

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.

Condition Intervention Phase
Critically Ill
Suspected Invasive Candidiasis
Drug: Caspofungin
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pharmacokinetics and Optimal Dosage of Caspofungin in Critically Ill Patients With Suspected Invasive Candidiasis

Resource links provided by NLM:

Further study details as provided by University Medical Center Groningen:

Primary Outcome Measures:
  • The optimal dosage of caspofungin in relation to adequate exposure (measured as AUC) in critically ill patients. [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Pharmacokinetic parameters of caspofungin in critically ill patients. [ Time Frame: 3 days ] [ Designated as safety issue: No ]
  • Correlation of pharmacokinetic parameters and the plasma concentration of caspofungin with disease severity scores. [ Time Frame: 3 days ] [ Designated as safety issue: No ]
  • Correlation of the plasma concentration of caspofungin with candida eradication. [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • Correlation of the plasma concentration of caspofungin with inflammation parameters. [ Time Frame: 3 days ] [ Designated as safety issue: No ]
  • AUC/MIC ratio and highest observed plasma concentration (Cmax)/MIC ratio. [ Time Frame: 7 days ] [ Designated as safety issue: No ]
  • Constructing a pharmacokinetic model of caspofungin in critically ill patients. [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • Drug-related adverse events of caspofungin. [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]

Enrollment: 20
Study Start Date: November 2013
Study Completion Date: October 2015
Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Caspofungin
1 arm, dose adjustment of caspofungin when exposure is inadequate
Drug: Caspofungin


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01994096

University Medical Centre Groningen
Groningen, Netherlands, 9700 RB
Sponsors and Collaborators
University Medical Center Groningen
Principal Investigator: Jan-Willem Alffenaar, PharmD, PhD University Medical Center Groningen
  More Information

No publications provided

Responsible Party: JWC Alffenaar, PharmD, PhD, University Medical Center Groningen
ClinicalTrials.gov Identifier: NCT01994096     History of Changes
Other Study ID Numbers: NL41676.042.12
Study First Received: November 19, 2013
Last Updated: October 29, 2015
Health Authority: The Netherlands: the Central Committee on Research Involving Human Subjects (CCMO)

Additional relevant MeSH terms:
Candidiasis, Invasive
Critical Illness
Disease Attributes
Pathologic Processes
Anti-Infective Agents
Antifungal Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 24, 2015