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

June 20, 2018 updated by: Jason A Roberts, The University of Queensland

An International, Multi-centre Prospective Pharmacokinetic Evaluation of Antifungal Drug Exposure in Intensive Care Unit Patients Receiving Conventional Dosing Regimens

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.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Fekade B Sime, PhD
  • Phone Number: +61 412 181 027
  • Email: f.sime@uq.edu.au

Study Contact Backup

Study Locations

  • Australia
    • Queensland
      • Brisbane, Queensland, Australia, 4029
        • Recruiting
        • Royal Brisbane and Women's Hospital
        • Contact:
    • Victoria
  • Belgium
    • Antwerp
      • Edegem, Antwerp, Belgium, 2650
        • Recruiting
        • Antwerp University Hospital
        • Contact:
        • Contact:
          • Philippe Jorens
          • Phone Number: 003238215175
  • Canada
    • Manitoba
      • Winnipeg, Manitoba, Canada
        • Not yet recruiting
        • The Health Sciences Center University of Manitoba
        • Contact:
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, 1276
        • Not yet recruiting
        • Queen Elizabeth II Health Sciences Centre
        • Contact:
  • Finland
  • France
      • Nimes, France, 30029
      • Paris, France, 75018
        • Not yet recruiting
        • APHP Hôpital Bichat - Réanimation médicale et Maladies infectieuses
        • Contact:
      • Pessac, France
      • Pringy, France, 74374
  • Greece
      • Athens, Greece, 14569
        • Recruiting
        • Attikon University Hospital
        • Contact:
  • Hong Kong
    • Hong Kong SAR
      • Hong Kong, Hong Kong SAR, Hong Kong
        • Not yet recruiting
        • Prince Of Wales Hospital
        • Contact:
  • Italy
      • Pisa, Italy
      • Roma, Italy
      • Roma, Italy
      • Rome, Italy, 161
        • Not yet recruiting
        • Sapienza, Università di Roma
        • Contact:
      • Torino, Italy, 10126
        • Not yet recruiting
        • Azienda Ospedaliero Universitaria Citta della Salute e della Scienza di Torino
        • Contact:
        • Contact:
  • Malaysia
      • Kuala Lumpur, Malaysia, 50603
        • Not yet recruiting
        • University Malaya Medical Centre
        • Contact:
      • Serdang, Malaysia
        • Not yet recruiting
        • Hospital Serdang
        • Contact:
    • Johor
      • Johor Bahru, Johor, Malaysia, 80100
        • Not yet recruiting
        • Hospital Sultan Ismail
        • Contact:
    • Kelantan
      • Kota Bharu, Kelantan, Malaysia, 16150
        • Not yet recruiting
        • Hospital Universiti Sains Malasysia
        • Contact:
          • Mohd Zulfakar Bin Mazlan
          • Phone Number: +60129091447
          • Email: ulfakar@usm.my
    • Pahang
      • Kuantan, Pahang, Malaysia, 25100
        • Recruiting
        • Hospital Tengku Ampuan Afzan
        • Contact:
      • Kuantan, Pahang, Malaysia, 52200
        • Not yet recruiting
        • International Islamic University Malaysia Medical Center
        • Contact:
  • Netherlands
  • Portugal
      • Coimbra, Portugal, 3000-075
      • Coimbra, Portugal
      • Lisbon, Portugal
      • Porto, Portugal
      • Porto, Portugal
        • Recruiting
        • Instituto Portugues de Oncologia do Porto Francisco Gentil
        • Contact:
      • Vila Franca de Xira, Portugal
        • Not yet recruiting
        • Hospital Vila Franca de Xira
        • Contact:
  • Spain
      • Barcelona, Spain, 8003
      • Barcelona, Spain, 8035
        • Not yet recruiting
        • Hospital Universitario Vall d'Hebron
        • Contact:
      • Barcelona, Spain, 8907
      • Valencia, Spain, 46010
        • Not yet recruiting
        • Hospital Clinico Universitario de Valencia
        • Contact:
  • United States
    • Louisiana
      • New Orleans, Louisiana, United States, 70121
        • Not yet recruiting
        • Oschner Medical Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Seven days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mortality
Time Frame: 30 days
30-day mortality
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Queensland

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2017

Primary Completion (Anticipated)

September 1, 2018

Study Completion (Anticipated)

December 1, 2018

Study Registration Dates

First Submitted

April 21, 2017

First Submitted That Met QC Criteria

April 26, 2017

First Posted (Actual)

May 2, 2017

Study Record Updates

Last Update Posted (Actual)

June 21, 2018

Last Update Submitted That Met QC Criteria

June 20, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • SAFE-ICU Protocol V2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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