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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT03136926




Registration number
NCT03136926
Ethics application status
Date submitted
21/04/2017
Date registered
2/05/2017
Date last updated
21/06/2018

Titles & IDs
Public title
Screening Anti-Fungal Exposure in Intensive Care Units
Scientific title
An International, Multi-centre Prospective Pharmacokinetic Evaluation of Antifungal Drug Exposure in Intensive Care Unit Patients Receiving Conventional Dosing Regimens
Secondary ID [1] 0 0
SAFE-ICU Protocol V2
Universal Trial Number (UTN)
Trial acronym
SAFE-ICU
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Antifungal Agents 0 0
Condition category
Condition code

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Probability of therapeutic target attainment
Timepoint [1] 0 0
Seven days
Secondary outcome [1] 0 0
Mortality
Timepoint [1] 0 0
30 days

Eligibility
Key inclusion criteria
- 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)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- 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
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Unknown status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/01/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2018
Actual
Sample size
Target
150
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD,VIC
Recruitment hospital [1] 0 0
Royal Brisbane and Women's Hospital - Brisbane
Recruitment hospital [2] 0 0
The Royal Melbourne Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
4029 - Brisbane
Recruitment postcode(s) [2] 0 0
3050 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Louisiana
Country [2] 0 0
Belgium
State/province [2] 0 0
Antwerp
Country [3] 0 0
Belgium
State/province [3] 0 0
Brussels
Country [4] 0 0
Belgium
State/province [4] 0 0
Gent
Country [5] 0 0
Belgium
State/province [5] 0 0
Leuven
Country [6] 0 0
Belgium
State/province [6] 0 0
Lodelinsart
Country [7] 0 0
Belgium
State/province [7] 0 0
Mons
Country [8] 0 0
Belgium
State/province [8] 0 0
Ottignies
Country [9] 0 0
Canada
State/province [9] 0 0
Manitoba
Country [10] 0 0
Canada
State/province [10] 0 0
Nova Scotia
Country [11] 0 0
Finland
State/province [11] 0 0
Helsinki
Country [12] 0 0
Finland
State/province [12] 0 0
Joensuu
Country [13] 0 0
Finland
State/province [13] 0 0
Kuopio
Country [14] 0 0
Finland
State/province [14] 0 0
Lahti
Country [15] 0 0
Finland
State/province [15] 0 0
Tampere
Country [16] 0 0
Finland
State/province [16] 0 0
Turku
Country [17] 0 0
France
State/province [17] 0 0
Nimes
Country [18] 0 0
France
State/province [18] 0 0
Paris
Country [19] 0 0
France
State/province [19] 0 0
Pessac
Country [20] 0 0
France
State/province [20] 0 0
Pringy
Country [21] 0 0
Greece
State/province [21] 0 0
Athens
Country [22] 0 0
Hong Kong
State/province [22] 0 0
Hong Kong SAR
Country [23] 0 0
Italy
State/province [23] 0 0
Pisa
Country [24] 0 0
Italy
State/province [24] 0 0
Roma
Country [25] 0 0
Italy
State/province [25] 0 0
Rome
Country [26] 0 0
Italy
State/province [26] 0 0
Torino
Country [27] 0 0
Malaysia
State/province [27] 0 0
Johor
Country [28] 0 0
Malaysia
State/province [28] 0 0
Kelantan
Country [29] 0 0
Malaysia
State/province [29] 0 0
Pahang
Country [30] 0 0
Malaysia
State/province [30] 0 0
Kuala Lumpur
Country [31] 0 0
Malaysia
State/province [31] 0 0
Serdang
Country [32] 0 0
Netherlands
State/province [32] 0 0
Nijmegen
Country [33] 0 0
Portugal
State/province [33] 0 0
Coimbra
Country [34] 0 0
Portugal
State/province [34] 0 0
Lisbon
Country [35] 0 0
Portugal
State/province [35] 0 0
Porto
Country [36] 0 0
Portugal
State/province [36] 0 0
Vila Franca de Xira
Country [37] 0 0
Spain
State/province [37] 0 0
Barcelona
Country [38] 0 0
Spain
State/province [38] 0 0
Valencia

Funding & Sponsors
Primary sponsor type
Other
Name
The University of Queensland
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT03136926
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Jason A Roberts, PhD
Address 0 0
The University of Queensland
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Fekade B Sime, PhD
Address 0 0
Country 0 0
Phone 0 0
+61 412 181 027
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT03136926