Optimal Dosage of Caspofungin in Critically Ill Patients

• Sponsor: University Medical Center Groningen (Other)
• Overall Status: Completed
• CT.gov ID: NCT01994096
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Arm: 1
• Duration (Months): 23
• Patients Per Site Per Month: 0.9

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Critically Ill; Suspected Invasive Candidiasis	Drug: Caspofungin	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 20 participants
• Allocation: N/A
• 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
• Study Start Date: Nov 1, 2013
• Actual Primary Completion Date: Oct 1, 2015
• Actual Study Completion Date: Oct 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Caspofungin 1 arm, dose adjustment of caspofungin when exposure is inadequate	Drug: Caspofungin

Outcome Measures

Primary Outcome Measures

1. The optimal dosage of caspofungin in relation to adequate exposure (measured as AUC) in critically ill patients. [7 days]

Secondary Outcome Measures

1. Pharmacokinetic parameters of caspofungin in critically ill patients. [3 days]

2. Correlation of pharmacokinetic parameters and the plasma concentration of caspofungin with disease severity scores. [3 days]

3. Correlation of the plasma concentration of caspofungin with candida eradication. [28 days]

4. Correlation of the plasma concentration of caspofungin with inflammation parameters. [3 days]

5. AUC/MIC ratio and highest observed plasma concentration (Cmax)/MIC ratio. [7 days]

6. Constructing a pharmacokinetic model of caspofungin in critically ill patients. [28 days]

7. Drug-related adverse events of caspofungin. [28 days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: JWC Alffenaar, PharmD, PhD, University Medical Center Groningen
• ClinicalTrials.gov Identifier: NCT01994096
• Other Study ID Numbers: NL41676.042.12
• First Posted: Nov 25, 2013
• Last Update Posted: Oct 30, 2015
• Last Verified: Oct 1, 2015

• Additional relevant MeSH terms: Candidiasis; Candidiasis, Invasive; Critical Illness; Caspofungin

Study Results

No Results Posted as of Oct 30, 2015