Pharmacokinetics of antifungal medications are considered inherently more unpredictable than most antibacterials.

The SAFE-ICU (Screening Anti-Fungal Exposure in Intensive Care Units) study will link our international collaborators to generate new knowledge on the adequacy of the current antifungal dosing of caspofungin, micafungin, anidulafungin, fluconazole, voriconazole, posaconazole, isavuconazole and amphotericin B, in a large cohort of ICU patients.

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Adequate antifungal therapy is a critical determinant of survival in patients admitted to an ICU with fungal infections. Critical illness can alter the way the human body handles antifungal agents, i.e., how drugs are distributed in the body and removed from the body. Consequently, these alterations can increase the risk of inappropriate antifungal exposure that may lead to adverse outcomes. Developing an evidence-based antifungal dosing guideline is of global significance and should be considered a priority to improving clinical outcomes for critically ill patients receiving antifungal agents.

The aim of the SAFE-ICU Study is to develop optimised antifungal dosing guidelines for ICU patients with life-threatening infections that account for patient characteristics.

This is a multi-national pharmacokinetic study that encompasses adult ICUs globally. A minimum of 12 ICUs are to be considered, with 80 ICUs aimed as the maximum for the scope of this study.

The SAFE-ICU study will document antifungal dosing regimens in the largest cohort of ICU patients across the world and provide evidence on whether conventional dosing of antifungal drugs achieves drug exposures associated with optimal outcomes and will be used in the development of antifungal dosing algorithms.

ClinicalTrials.gov Identifier: NCT03136926
https://clinicaltrials.gov/ct2/show/study/NCT03136926

Relevant publications

Sime, Fekade B., Stuart, Janine, Butler, Jenie, Starr, Therese, Wallis, Steven C., Pandey, Saurabh, Lipman, Jeffrey and Roberts, Jason A. (2018) A pharmacokinetic case study of intravenous posaconazole in a critically ill patient with hypoalbuminemia receiving continuous venovenous hemodiafiltration. International Journal of Antimicrobial Agents, . doi:10.1016/j.ijantimicag.2018.07.008

Maseda, Emilio, Grau, Santiago, Luque, Sonia, Castillo-Mafla, Maria-Pilar, Suárez-de-la-Rica, Alejandro, Montero-Feijoo, Ana, Salgado, Patricia, Gimenez, Maria-Jose, García-Bernedo, Carlos A., Gilsanz, Fernando and Roberts, Jason A. (2018) Population pharmacokinetics/pharmacodynamics of micafungin against Candida species in obese, critically ill, and morbidly obese critically ill patients. Critical Care, 22 1: 94. doi:10.1186/s13054-018-2019-8

Sime, Fekade B., Stuart, Janine, Butler, Jenie, Starr, Therese, Wallis, Steven C., Pandey, Saurabh, Lipman, Jeffrey and Roberts, Jason A. (2018) Pharmacokinetics of intravenous posaconazole in critically ill patients. Antimicrobial Agents and Chemotherapy, 62 6: e00242-18. doi:10.1128/AAC.00242-18

Project members

Jason Roberts

Professor Jason Roberts

Director
CRE RESPOND
Acting Director
UQ Centre for Clinical Research
NHMRC Leadership Fellow
The University of Queensland
Pharmacist Consultant
Royal Brisbane & Women’s Hospital
Fekade Sime

Dr Fekade Sime

Dynamic bacterial-kill workstream lead
CRE RESPOND
NHMRC Emerging Leadership Fellow
UQ Centre for Clinical Research

Professor Jeffrey Lipman

Critical Care Research, Translation and Training Lead
CRE RESPOND
Emeritus Professor
UQ Centre for Clinical Research
Patty Hernandez Mitre

Dr Patty Hernandez Mitre

Postdoctoral Research Fellow
UQ Centre for Clinical Research

Professor Jan De Waele

European Collaboration Co-Lead
CRE RESPOND
Critical Care Physician
Ghent University Hospital

Professor Jean-Yves Lefrant

European Collaboration Co-Lead
CRE RESPOND
ICU Physician and Chair of AZUREA Research
University of Nîmes

Professor Jordi Rello

Professor of Medicine
Universitat Autònoma de Barcelona
Chief of the Critical Care Department
Vall d'Hebron University Hospital

Professor Monica Slavin

Immunocompromised Host Research and Translation Lead
CRE RESPOND
NHMRC Leadership Fellow and Infectious Diseases Physician
Royal Melbourne Hospital
Director
National Centre of Research Excellence Infections in Cancer