Optimal Dosage of Caspofungin in Critically Ill Patients

NCT01994096 | Completed Phase 4

• 1 other identifier: NL41676.042.12
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Critically Ill; Suspected Invasive Candidiasis

Outcome Measures

Primary Outcomes (1)

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

  7 days

Secondary Outcomes (7)

• Pharmacokinetic parameters of caspofungin in critically ill patients.

  3 days

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

  3 days

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

  28 days

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

  3 days

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

  7 days

Study Arms (1)

Caspofungin

EXPERIMENTAL

1 arm, dose adjustment of caspofungin when exposure is inadequate

Drug: Caspofungin

Interventions

Caspofungin DRUG

Caspofungin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Treatment with caspofungin.
• Admission to an ICU.
• Age ≥ 18 years.
• Suspected invasive candidiasis, established by the physician.

You may not qualify if:

• Blood sampling by central venous catheter or peripheral cannula not possible.

Sponsors & Collaborators

• University Medical Center Groningen: lead

Study Sites (1)

University Medical Centre Groningen

Groningen, Provincie Groningen, 9700 RB, Netherlands

Location

Related Publications (1)

• van der Elst KC, Veringa A, Zijlstra JG, Beishuizen A, Klont R, Brummelhuis-Visser P, Uges DR, Touw DJ, Kosterink JG, van der Werf TS, Alffenaar JC. Low Caspofungin Exposure in Patients in Intensive Care Units. Antimicrob Agents Chemother. 2017 Jan 24;61(2):e01582-16. doi: 10.1128/AAC.01582-16. Print 2017 Feb.

  PMID: 27855112 DERIVED

MeSH Terms

Conditions

Critical Illness

Interventions

Caspofungin

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Lipopeptides; Lipids; Peptides; Amino Acids, Peptides, and Proteins; Echinocandins; Peptides, Cyclic

Study Officials

• Jan-Willem Alffenaar, PharmD, PhD

  University Medical Center Groningen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PharmD, PhD

Study Record Dates

• First Submitted: November 19, 2013
• First Posted: November 25, 2013
• Study Start: November 1, 2013
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2015
• Last Updated: October 30, 2015

Record last verified: 2015-10

Locations

NL (1)