Optimal Dosage of Caspofungin in Critically Ill Patients

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by University Medical Centre Groningen
Sponsor:
Information provided by (Responsible Party):
JWC Alffenaar, University Medical Centre Groningen
ClinicalTrials.gov Identifier:
NCT01994096
First received: November 19, 2013
Last updated: June 12, 2014
Last verified: June 2014
  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: 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 Centre 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 ]

Estimated Enrollment: 20
Study Start Date: November 2013
Estimated Primary Completion Date: April 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Contacts
Contact: Jan-Willem Alffenaar, PharmD, PhD 0031503614070 j.w.c.alffenaar@umcg.nl

Locations
Netherlands
University Medical Centre Groningen Recruiting
Groningen, Netherlands, 9700 RB
Contact: Jan-Willem Alffenaar, PharmD, PhD    0031503614070    j.w.c.alffenaar@umcg.nl   
Principal Investigator: Jan-Willem Alffenaar, PharmD, PhD         
Sponsors and Collaborators
University Medical Centre Groningen
Investigators
Principal Investigator: Jan-Willem Alffenaar, PharmD, PhD University Medical Centre Groningen
  More Information

No publications provided

Responsible Party: JWC Alffenaar, PharmD, PhD, University Medical Centre Groningen
ClinicalTrials.gov Identifier: NCT01994096     History of Changes
Other Study ID Numbers: NL41676.042.12
Study First Received: November 19, 2013
Last Updated: June 12, 2014
Health Authority: The Netherlands: the Central Committee on Research Involving Human Subjects (CCMO)

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

ClinicalTrials.gov processed this record on August 28, 2014