Skip to main content
OpenTrials
Completed

NCT Number: NCT01994096

Optimal Dosage of Caspofungin in Critically Ill Patients

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Critically Ill Critical Illness Disease Attributes Pathologic Processes Pathological Conditions, Signs and Symptoms Suspected Invasive Candidiasis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University Medical Centre Groningen

Groningen, Provincie Groningen, 9700 RB, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Caspofungin

Drug

Primary outcomes

  1. The optimal dosage of caspofungin in relation to adequate exposure (measured as AUC) in critically ill patients.

    Time frame: 7 days

Secondary outcomes

  1. Pharmacokinetic parameters of caspofungin in critically ill patients.

    Time frame: 3 days

  2. Correlation of pharmacokinetic parameters and the plasma concentration of caspofungin with disease severity scores.

    Time frame: 3 days

  3. Correlation of the plasma concentration of caspofungin with candida eradication.

    Time frame: 28 days

  4. Correlation of the plasma concentration of caspofungin with inflammation parameters.

    Time frame: 3 days

  5. AUC/MIC ratio and highest observed plasma concentration (Cmax)/MIC ratio.

    Time frame: 7 days

  6. Constructing a pharmacokinetic model of caspofungin in critically ill patients.

    Time frame: 28 days

  7. Drug-related adverse events of caspofungin.

    Time frame: 28 days

Sponsors and collaborators

Lead sponsor

University Medical Center Groningen

Other

Registry information

Official study title

Pharmacokinetics and Optimal Dosage of Caspofungin in Critically Ill Patients With Suspected Invasive Candidiasis

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Nov 25, 2013
Registry last updated
Oct 30, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.