A protocol for an international, multicentre pharmacokinetic study for screening Antifungal exposure in intensive care units: the SAFE-ICU study

Roberts, Jason A. and Sime, Fekade and Lipman, Jeffrey and Hernandez-Mitre, Maria Patricia and Baptista, João P and Brüggemann, Roger J. and Darvall, Jai and Waele, Jan J. De and Dimopoulos, George and Lefrant, Jean-Yves and Mat Nor, Mohd Basri and Rello, Jordi and Seoane, Leonardo and Slavin, Monica A. and Valkonen, Miia Maaria and Venditti, Mario and Wong, Wai Tat and Zeitlinger, Markus and Roger, Claire (2023) A protocol for an international, multicentre pharmacokinetic study for screening Antifungal exposure in intensive care units: the SAFE-ICU study. Critical Care and Resuscitation, 25 (1). pp. 1-5. ISSN 1441-2772

Preview	PDF (SCOPUS) - Supplemental Material Download (169kB) | Preview
	PDF (Article) - Published Version Restricted to Repository staff only Download (227kB) | Request a copy

Abstract

Objective: To describe whether contemporary dosing of antifungal drugs achieves therapeutic exposures in critically ill patients that are associated with optimal outcomes. Adequate antifungal therapy is a key determinant of survival of critically ill patients with fungal infections. Critical illness can alter an antifungal agents’ pharmacokinetics, increasing the risk of inappropriate antifungal exposure that may lead to treatment failure and/or toxicity. Design, setting and participants: This international, multicentre, observational pharmacokinetic study will comprise adult critically ill patients prescribed antifungal agents including fluconazole, voriconazole, posaconazole, isavuconazole, caspofungin, micafungin, anidulafungin, and amphotericin B for the treatment or prophylaxis of invasive fungal disease. A minimum of 12 patients are targeted for enrolment for each antifungal agent, across 12 countries and 30 intensive care units to perform descriptive pharmacokinetics. Pharmacokinetic sampling will occur during two dosing intervals (occasions): firstly, between days 1 and 3, and secondly, between days 4 and 7 of the antifungal course, collecting three samples per occasion. Patients’ demographic and clinical data will be collected. Main outcome measures: The primary endpoint of the study is attainment of pharmacokinetic/pharmacodynamic target exposures that are associated with optimal efficacy. Thirty-day mortality will also be measured. Results and conclusions: This study will describe whether contemporary antifungal drug dosing achieves drug exposures associated with optimal outcomes. Data will also be used for the development of antifungal dosing algorithms for critically ill patients. Optimised drug dosing should be considered a priority for improving clinical outcomes for critically ill patients with fungal infections.

Item Type:	Article (Journal)
Uncontrolled Keywords:	Antifungal agents Dosing Critically ill Intensive care unit Pharmacokinetics
Subjects:	R Medicine > RC Internal medicine > RC82 Medical Emergencies, Critical Care, Intensive Care, First Aid
Kulliyyahs/Centres/Divisions/Institutes (Can select more than one option. Press CONTROL button):	Kulliyyah of Medicine Kulliyyah of Medicine > Department of Anaesthesiology & Intensive Care
Depositing User:	Dr. Mohd Basri Mat Nor
Date Deposited:	17 Jan 2024 11:45
Last Modified:	17 Jan 2024 12:01
URI:	http://irep.iium.edu.my/id/eprint/110190

Actions (login required)

View Item