Screening Anti-Fungal Exposure in Intensive Care Units
- Conditions
- Antifungal Agents
- Registration Number
- NCT03136926
- Lead Sponsor
- The University of Queensland
- Brief Summary
Adequate antifungal therapy is a critical determinant of survival in patients admitted to an Intensive Care Unit (ICU) with suspected or proven fungal infections. Critical illness can alter the way human body handles antifungal agents, i.e. how the drugs are distributed in the body and removed from the body. Consequently, these changes can increase the risk of inappropriate antifungal exposure that may lead to adverse consequence on patients' outcome. Developing an evidence-based antifungal dosing guideline is of global significance and should be considered a priority to improving clinical outcomes for patients receiving antifungal agents
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 150
- Age ≥ 18
- 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)
- Aged < 18 years of age
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Probability of therapeutic target attainment Seven days Probability of attainment of therapeutic target associated with optimal efficacy will be determined by measuring the ratio of area under the concentration-time curve (AUC) to the minimum inhibitory concentration (MIC).
- Secondary Outcome Measures
Name Time Method Mortality 30 days 30-day mortality
Trial Locations
- Locations (47)
Hospital de Bellvitge
🇪🇸Barcelona, Spain
Azienda Ospedaliero Universitaria Città della Salute e della Scienza di Torino
🇮🇹Torino, Italy
International Islamic University Malaysia Medical Center
🇲🇾Kuantan, Pahang, Malaysia
Hospital Universitario Vall d'Hebron
🇪🇸Barcelona, Spain
Hospital Del Mar
🇪🇸Barcelona, Spain
Hospital Clínico Universitario de Valencia
🇪🇸Valencia, Spain
Hospital Sultan Ismail
🇲🇾Johor Bahru, Johor, Malaysia
APHP Hôpital Bichat - Réanimation médicale et Maladies infectieuses
🇫🇷Paris, France
The Royal Melbourne Hospital
🇦🇺Melbourne, Victoria, Australia
Royal Brisbane and Women's Hospital
🇦🇺Brisbane, Queensland, Australia
Antwerp University Hospital
🇧🇪Edegem, Antwerp, Belgium
Uz Brussel
🇧🇪Brussels, Belgium
The Health Sciences Center University of Manitoba
🇨🇦Winnipeg, Manitoba, Canada
Kuopio University Hospital
🇫🇮Kuopio, Finland
CHRU de Nîmes - Hôpital Universitaire Carémeau
🇫🇷Nimes, France
Chu de BORDEAUX Hôpital Haut-Leveque - Réanimation
🇫🇷Pessac, France
CH Annecy Genevois - Réanimation
🇫🇷Pringy, France
ATTIKON University Hospital
🇬🇷Athens, Greece
Azienda Ospedaliera Universitaria Pisana
🇮🇹Pisa, Italy
Ospedale San Filippo Neri
🇮🇹Roma, Italy
San Giovanni Addolorata Hospital
🇮🇹Roma, Italy
Sapienza, Universita di roma
🇮🇹Rome, Italy
Helsinki University Central Hospital
🇫🇮Helsinki, Finland
Päijänne Tavastia Central Hospital
🇫🇮Lahti, Finland
Tampere University Hospital
🇫🇮Tampere, Finland
Ghent University hospital
🇧🇪Gent, Belgium
CHU de Charleroi site Marie Curie
🇧🇪Lodelinsart, Belgium
Universitary Saint-Luc hospital
🇧🇪Brussels, Belgium
UZ Gasthuisberg
🇧🇪Leuven, Belgium
Hospital Serdang
🇲🇾Serdang, Malaysia
Centro Hospitalar Universitario de coimbra
🇵🇹Coimbra, Portugal
Hospital Vila Franca de Xira
🇵🇹Vila Franca de Xira, Portugal
Oschner Medical Center
🇺🇸New Orleans, Louisiana, United States
Chu Ambroise Pare
🇧🇪Mons, Belgium
North-Karelia Central Hospital
🇫🇮Joensuu, Finland
Clinique Saint-Pierre
🇧🇪Ottignies, Belgium
Hospital Geral
🇵🇹Coimbra, Portugal
Hospital de Santa Maria
🇵🇹Lisbon, Portugal
Turku University Hospital
🇫🇮Turku, Finland
Radboud University Nijmegen Medical Centre
🇳🇱Nijmegen, Netherlands
Instituto Português de Oncologia do Porto Francisco Gentil
🇵🇹Porto, Portugal
Hospital Tengku Ampuan Afzan
🇲🇾Kuantan, Pahang, Malaysia
University Malaya Medical Centre
🇲🇾Kuala Lumpur, Malaysia
Hospital S. João
🇵🇹Porto, Portugal
Hospital Universiti Sains Malasysia
🇲🇾Kota Bharu, Kelantan, Malaysia
Queen Elizabeth II Health Sciences Centre
🇨🇦Halifax, Nova Scotia, Canada
Prince of Wales Hospital
🇭🇰Hong Kong, Hong Kong SAR, Hong Kong