Optimal Dosage of Caspofungin in Critically Ill Patients

University Medical Center Groningen (UMCG)

Status and phase: Completed; Phase 4

Conditions: Critically Ill; Suspected Invasive Candidiasis

Treatments: Drug: Caspofungin

Study type: Interventional

Funder types: Other

Identifiers

NCT01994096

NL41676.042.12

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Caspofungin

Experimental group

Description:

1 arm, dose adjustment of caspofungin when exposure is inadequate

Treatment:

Drug: Caspofungin