Optimal Dosage of Caspofungin in Critically Ill Patients

Critically Ill Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01994096
• Other study ID #: NL41676.042.12
• Status: Completed
• Phase: Phase 4
• First received: November 19, 2013
• Last updated: October 29, 2015
• Start date: November 2013
• Est. completion date: October 2015

Study information

• Verified date: October 2015
• Source: University Medical Center Groningen
• Contact: n/a
• Is FDA regulated: No
• Health authority: The Netherlands: the Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Candidiasis
• Candidiasis, Invasive
• Critical Illness
• Critically Ill
• Suspected Invasive Candidiasis

Intervention

Drug:
• Caspofungin

Locations

Country	Name	City	State
Netherlands	University Medical Centre Groningen	Groningen

Sponsors (1)

Lead Sponsor	Collaborator
University Medical Center Groningen

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The optimal dosage of caspofungin in relation to adequate exposure (measured as AUC) in critically ill patients.		7 days	Yes
Secondary	Pharmacokinetic parameters of caspofungin in critically ill patients.		3 days	No
Secondary	Correlation of pharmacokinetic parameters and the plasma concentration of caspofungin with disease severity scores.		3 days	No
Secondary	Correlation of the plasma concentration of caspofungin with candida eradication.		28 days	No
Secondary	Correlation of the plasma concentration of caspofungin with inflammation parameters.		3 days	No
Secondary	AUC/MIC ratio and highest observed plasma concentration (Cmax)/MIC ratio.		7 days	No
Secondary	Constructing a pharmacokinetic model of caspofungin in critically ill patients.		28 days	No
Secondary	Drug-related adverse events of caspofungin.		28 days	Yes