DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



Optimal Dosage of Caspofungin in Critically Ill Patients

Information source: University Medical Center Groningen
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Critically Ill; Suspected Invasive Candidiasis

Intervention: Caspofungin (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: University Medical Center Groningen

Official(s) and/or principal investigator(s):
Jan-Willem Alffenaar, PharmD, PhD, Principal Investigator, Affiliation: University Medical Center Groningen

Overall contact:
Jan-Willem Alffenaar, PharmD, PhD, Phone: 0031503614070, Email: j.w.c.alffenaar@umcg.nl

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.

Clinical Details

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

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

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

Secondary outcome:

Pharmacokinetic parameters of caspofungin in critically ill patients.

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

Correlation of the plasma concentration of caspofungin with candida eradication.

Correlation of the plasma concentration of caspofungin with inflammation parameters.

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

Constructing a pharmacokinetic model of caspofungin in critically ill patients.

Drug-related adverse events of caspofungin.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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.

Locations and Contacts

Jan-Willem Alffenaar, PharmD, PhD, Phone: 0031503614070, Email: j.w.c.alffenaar@umcg.nl

University Medical Centre Groningen, Groningen 9700 RB, Netherlands; Recruiting
Jan-Willem Alffenaar, PharmD, PhD, Phone: 0031503614070, Email: j.w.c.alffenaar@umcg.nl
Jan-Willem Alffenaar, PharmD, PhD, Principal Investigator
Additional Information

Starting date: November 2013
Last updated: June 17, 2015

Page last updated: August 20, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017