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Screening Anti-Fungal Exposure in Intensive Care Units (SAFE-ICU)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03136926
Recruitment Status : Unknown
Verified June 2018 by Jason A Roberts, The University of Queensland.
Recruitment status was:  Recruiting
First Posted : May 2, 2017
Last Update Posted : June 21, 2018
Information provided by (Responsible Party):
Jason A Roberts, 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.

Condition or disease
Antifungal Agents

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Study Type : Observational
Estimated 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 : January 2017
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : December 2018

Primary Outcome Measures :
  1. Probability of therapeutic target attainment [ Time Frame: 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 [ Time Frame: 30 days ]
    30-day mortality

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The study population will comprise adult critically ill patients (≥18 years) requiring ICU care, including both surgical and medical ICU patients. Representation of the study population will be ensured by enrolling all patients at the study sites who meet the study criteria during the study period. The study will recruit patients prescribed to receive any of the chosen systemic antifungal agents regardless of whether prescribed for treatment, pre-emptive treatment or for prophylaxis.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03136926

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Contact: Fekade B Sime, PhD +61 412 181 027 f.sime@uq.edu.au
Contact: Jason A Roberts, PhD +61 7 3365 5114 j.roberts2@uq.edu.au

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Sponsors and Collaborators
The University of Queensland
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Principal Investigator: Jason A Roberts, PhD The University of Queensland
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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    Key Record Dates
Last Update Posted: June 21, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No