Optimal Dosage of Caspofungin in Critically Ill Patients

October 29, 2015 updated by: JWC Alffenaar, University Medical Center Groningen

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

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.

Study Overview

Status

Completed

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Groningen, Netherlands, 9700 RB
        • University Medical Centre Groningen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Caspofungin
1 arm, dose adjustment of caspofungin when exposure is inadequate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The optimal dosage of caspofungin in relation to adequate exposure (measured as AUC) in critically ill patients.
Time Frame: 7 days
7 days

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2013

Primary Completion (ACTUAL)

October 1, 2015

Study Completion (ACTUAL)

October 1, 2015

Study Registration Dates

First Submitted

November 19, 2013

First Submitted That Met QC Criteria

November 22, 2013

First Posted (ESTIMATE)

November 25, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

October 30, 2015

Last Update Submitted That Met QC Criteria

October 29, 2015

Last Verified

October 1, 2015

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Critically Ill

Clinical Trials on Caspofungin

3
Subscribe