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SAFE-ICU: Screening Anti-Fungal Exposure in Intensive Care Units

Sponsor
The University of Queensland (Other)
Overall Status
Unknown status
CT.gov ID
NCT03136926
Collaborator
(none)
150
Enrollment
47
Locations
23
Anticipated Duration (Months)
3.2
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

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:

  1. 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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    150 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    An International, Multi-centre Prospective Pharmacokinetic Evaluation of Antifungal Drug Exposure in Intensive Care Unit Patients Receiving Conventional Dosing Regimens
    Actual Study Start Date :
    Jan 1, 2017
    Anticipated Primary Completion Date :
    Sep 1, 2018
    Anticipated Study Completion Date :
    Dec 1, 2018

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. Mortality [30 days]

      30-day mortality

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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)

    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Oschner Medical Center New Orleans Louisiana United States 70121
    2 Royal Brisbane and Women's Hospital Brisbane Queensland Australia 4029
    3 The Royal Melbourne Hospital Melbourne Victoria Australia 3050
    4 Antwerp University Hospital Edegem Antwerp Belgium 2650
    5 Uz Brussel Brussels Belgium 1090
    6 Universitary Saint-Luc hospital Brussels Belgium 1200
    7 Ghent University hospital Gent Belgium 9000
    8 UZ Gasthuisberg Leuven Belgium 3000
    9 CHU de Charleroi site Marie Curie Lodelinsart Belgium 6042
    10 Chu Ambroise Pare Mons Belgium 7000
    11 Clinique Saint-Pierre Ottignies Belgium 1340
    12 The Health Sciences Center University of Manitoba Winnipeg Manitoba Canada
    13 Queen Elizabeth II Health Sciences Centre Halifax Nova Scotia Canada 1276
    14 Helsinki University Central Hospital Helsinki Finland
    15 North-Karelia Central Hospital Joensuu Finland
    16 Kuopio University Hospital Kuopio Finland
    17 Päijänne Tavastia Central Hospital Lahti Finland
    18 Tampere University Hospital Tampere Finland
    19 Turku University Hospital Turku Finland
    20 CHRU de Nîmes - Hôpital Universitaire Carémeau Nimes France 30029
    21 APHP Hôpital Bichat - Réanimation médicale et Maladies infectieuses Paris France 75018
    22 Chu de BORDEAUX Hôpital Haut-Leveque - Réanimation Pessac France
    23 CH Annecy Genevois - Réanimation Pringy France 74374
    24 ATTIKON University Hospital Athens Greece 14569
    25 Prince of Wales Hospital Hong Kong Hong Kong SAR Hong Kong
    26 Azienda Ospedaliera Universitaria Pisana Pisa Italy
    27 Ospedale San Filippo Neri Roma Italy
    28 San Giovanni Addolorata Hospital Roma Italy
    29 Sapienza, Universita di roma Rome Italy 161
    30 Azienda Ospedaliero Universitaria Città della Salute e della Scienza di Torino Torino Italy 10126
    31 Hospital Sultan Ismail Johor Bahru Johor Malaysia 80100
    32 Hospital Universiti Sains Malasysia Kota Bharu Kelantan Malaysia 16150
    33 Hospital Tengku Ampuan Afzan Kuantan Pahang Malaysia 25100
    34 International Islamic University Malaysia Medical Center Kuantan Pahang Malaysia 52200
    35 University Malaya Medical Centre Kuala Lumpur Malaysia 50603
    36 Hospital Serdang Serdang Malaysia
    37 Radboud University Nijmegen Medical Centre Nijmegen Netherlands
    38 Centro Hospitalar Universitario de coimbra Coimbra Portugal 3000-075
    39 Hospital Geral Coimbra Portugal
    40 Hospital de Santa Maria Lisbon Portugal
    41 Hospital S. João Porto Portugal
    42 Instituto Português de Oncologia do Porto Francisco Gentil Porto Portugal
    43 Hospital Vila Franca de Xira Vila Franca de Xira Portugal
    44 Hospital Del Mar Barcelona Spain 8003
    45 Hospital Universitario Vall d'Hebron Barcelona Spain 8035
    46 Hospital de Bellvitge Barcelona Spain 8907
    47 Hospital Clínico Universitario de Valencia Valencia Spain 46010

    Sponsors and Collaborators

    • The University of Queensland

    Investigators

    • Principal Investigator: Jason A Roberts, PhD, The University of Queensland

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Jason A Roberts, Professor, The University of Queensland
    ClinicalTrials.gov Identifier:
    NCT03136926
    Other Study ID Numbers:
    • SAFE-ICU Protocol V2
    First Posted:
    May 2, 2017
    Last Update Posted:
    Jun 21, 2018
    Last Verified:
    Jun 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Jun 21, 2018