Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
150 participants
OBSERVATIONAL
2017-01-31
2018-12-31
Brief Summary
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The aim of the SAFE-ICU Study is to develop optimised antibiotic dosing guidelines for ICU patients with life-threatening infections that account for patient characteristics. This will be achieved through completion of the following aims:
i) Describe detailed demographic, clinical and plasma antibiotic concentration-time data in a large ICU patient cohort; ii) Perform a robust statistical analysis of the data collected in Aim 1 to develop an enhanced preliminary prediction algorithm for antifungal dosing.
This is a multi-national study and will enrol ICU patients who are prescribed an antifungal agent (fluconazole, voriconazole, posaconazole, isavuconazole, caspofungin, anidulafungin, micafungin or amphotericin B). A minimum of 12 patients per drug will be enrolled across at least 15 countries and up to 80 ICUs.
Eligible patients are those admitted to the ICU, who are prescribed an antifungal agent (fluconazole, voriconazole, posaconazole, isavuconazole, caspofungin, anidulafungin, micafungin or amphotericin B). Blood samples will be taken to measure drug concentration. Sampling will occur on two occasions, first during study days 1-3 and then a second time between days 4-7, each over an 8-24 hour period. Blood samples will be taken from a vascular access device already inserted for ICU patient care. Abdominal samples from abdominal indwelling drains already inserted peri operatively will also be collected on these two occasions in the subgroup of patients with intra-abdominal infection. Data on infection, various blood tests and patient specific data will be collected using a structured case report form (CRF). Patients will also be followed up 30 days after enrolment into the study to evaluate 30-day mortality.
Collected samples will be frozen and stored locally and then shipped in large batches for processing at Burns Trauma and Critical Care Research Centre, The University of Queensland, Australia. Data analysis for development of antifungal dosing algorithms will also be undertaken at The University of Queensland, Australia.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* Critically ill patients requiring ICU care
* Receiving enteral or intravenous therapy of antifungal of interest (triazole, echinocandin, amphotericin) including prophylaxis indication and antifungal therapy started in another unit (wards, operating room) for the same infectious episode
* Availability of suitable intravenous/intra-arterial access to facilitate sample collection
* Written informed consent has been obtained from the patient or their next of kin (according to local regulatory statements for ethical conduct of research at each study site)
Exclusion Criteria
* Pregnancy
* Consent not obtained (according to local regulatory statements for ethical conduct of research at each study site)
* Diagnosis with human immunodeficiency virus or hepatitis B or C or tuberculosis
18 Years
ALL
No
Sponsors
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The University of Queensland
OTHER
Responsible Party
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Jason A Roberts
Professor
Principal Investigators
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Jason A Roberts, PhD
Role: PRINCIPAL_INVESTIGATOR
The University of Queensland
Locations
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Oschner Medical Center
New Orleans, Louisiana, United States
Royal Brisbane and Women's Hospital
Brisbane, Queensland, Australia
The Royal Melbourne Hospital
Melbourne, Victoria, Australia
Antwerp University Hospital
Edegem, Antwerp, Belgium
Universitary Saint-Luc hospital
Brussels, Brussels Capital, Belgium
Uz Brussel
Brussels, , Belgium
Ghent University hospital
Ghent, , Belgium
UZ Gasthuisberg
Leuven, , Belgium
CHU de Charleroi site Marie Curie
Lodelinsart, , Belgium
Chu Ambroise Pare
Mons, , Belgium
Clinique Saint-Pierre
Ottignies, , Belgium
The Health Sciences Center University of Manitoba
Winnipeg, Manitoba, Canada
Queen Elizabeth II Health Sciences Centre
Halifax, Nova Scotia, Canada
Helsinki University Central Hospital
Helsinki, , Finland
North-Karelia Central Hospital
Joensuu, , Finland
Kuopio University Hospital
Kuopio, , Finland
Päijänne Tavastia Central Hospital
Lahti, , Finland
Tampere University Hospital
Tampere, , Finland
Turku University Hospital
Turku, , Finland
CHRU de Nîmes - Hôpital Universitaire Carémeau
Nîmes, , France
APHP Hôpital Bichat - Réanimation médicale et Maladies infectieuses
Paris, , France
Chu de BORDEAUX Hôpital Haut-Leveque - Réanimation
Pessac, , France
CH Annecy Genevois - Réanimation
Pringy, , France
ATTIKON University Hospital
Athens, , Greece
Prince of Wales Hospital
Hong Kong, Hong Kong SAR, Hong Kong
Azienda Ospedaliera Universitaria Pisana
Pisa, , Italy
Ospedale San Filippo Neri
Roma, , Italy
San Giovanni Addolorata Hospital
Roma, , Italy
Sapienza, Universita di roma
Rome, , Italy
Azienda Ospedaliero Universitaria Città della Salute e della Scienza di Torino
Torino, , Italy
Hospital Sultan Ismail
Johor Bahru, Johor, Malaysia
Hospital Universiti Sains Malasysia
Kota Bharu, Kelantan, Malaysia
Hospital Tengku Ampuan Afzan
Kuantan, Pahang, Malaysia
International Islamic University Malaysia Medical Center
Kuantan, Pahang, Malaysia
University Malaya Medical Centre
Kuala Lumpur, , Malaysia
Hospital Serdang
Serdang, , Malaysia
Radboud University Nijmegen Medical Centre
Nijmegen, , Netherlands
Centro Hospitalar Universitario de coimbra
Coimbra, , Portugal
Hospital Geral
Coimbra, , Portugal
Hospital de Santa Maria
Lisbon, , Portugal
Hospital S. João
Porto, , Portugal
Instituto Português de Oncologia do Porto Francisco Gentil
Porto, , Portugal
Hospital Vila Franca de Xira
Vila Franca de Xira, , Portugal
Hospital Del Mar
Barcelona, , Spain
Hospital Universitario Vall d'Hebron
Barcelona, , Spain
Hospital de Bellvitge
Barcelona, , Spain
Hospital Clínico Universitario de Valencia
Valencia, , Spain
Countries
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Central Contacts
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Facility Contacts
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Philippe Jorens
Role: backup
References
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Roberts JA, Sime FB, Lipman J, Hernandez-Mitre MP, Baptista JP, Bruggemann RJ, Darvall J, De Waele JJ, Dimopoulos G, Lefrant JY, Mat Nor MB, Rello J, Seoane L, Slavin MA, Valkonen M, Venditti M, Ceccarelli G, Wong WT, Zeitlinger M, Roger C. Are contemporary antifungal doses sufficient for critically ill patients? Outcomes from an international, multicenter pharmacokinetics study for Screening Antifungal Exposure in Intensive Care Units-the SAFE-ICU study. Intensive Care Med. 2025 Feb;51(2):302-317. doi: 10.1007/s00134-025-07793-5. Epub 2025 Feb 3.
Other Identifiers
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SAFE-ICU Protocol V2
Identifier Type: -
Identifier Source: org_study_id
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