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Optimal Dosage of Caspofungin in Critically Ill Patients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01994096
First Posted: November 25, 2013
Last Update Posted: October 30, 2015
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):
JWC Alffenaar, University Medical Center Groningen
  Purpose

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: Intervention Model: Single Group Assignment
Masking: None (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 JWC Alffenaar, 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 ]

Secondary Outcome Measures:
  • Pharmacokinetic parameters of caspofungin in critically ill patients. [ Time Frame: 3 days ]
  • Correlation of pharmacokinetic parameters and the plasma concentration of caspofungin with disease severity scores. [ Time Frame: 3 days ]
  • Correlation of the plasma concentration of caspofungin with candida eradication. [ Time Frame: 28 days ]
  • Correlation of the plasma concentration of caspofungin with inflammation parameters. [ Time Frame: 3 days ]
  • AUC/MIC ratio and highest observed plasma concentration (Cmax)/MIC ratio. [ Time Frame: 7 days ]
  • Constructing a pharmacokinetic model of caspofungin in critically ill patients. [ Time Frame: 28 days ]
  • Drug-related adverse events of caspofungin. [ Time Frame: 28 days ]

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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01994096


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: JWC Alffenaar, PharmD, PhD, University Medical Center Groningen
ClinicalTrials.gov Identifier: NCT01994096     History of Changes
Other Study ID Numbers: NL41676.042.12
First Submitted: November 19, 2013
First Posted: November 25, 2013
Last Update Posted: October 30, 2015
Last Verified: October 2015

Additional relevant MeSH terms:
Critical Illness
Candidiasis
Candidiasis, Invasive
Disease Attributes
Pathologic Processes
Mycoses
Invasive Fungal Infections
Caspofungin
Echinocandins
Antifungal Agents
Anti-Infective Agents