AzTrials
AzTrials

Fungal InfectionsfungalAiNCT03793231

fungalAi for Fungal Surveillance & Antifungal Stewardship

An observational study of Fungal Infections, run by Bayside Health at 1 site in Australia.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

This national Australian study will validate and implement an effective approach to real-time electronic surveillance of fungal infections in patients with blood cancers using technology based on artificial intelligence. Read more about this study

Who is it for?
Any ageHealthy volunteers can take part
Conditions the study is for
Fungal Infections
What is being tested?
fungalAi platform technology
How many people
1,000 participants
Where
1 siteAustralia
Study dates
1 Jan 2019to 30 Dec 2020
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Study population: Adults and children with blood cancers under the haematology service at participating sites inclusive of inpatient and ambulatory care patients.

Who may be able to join

  • Adults and children
  • Under the haematology service at participating sites
  • Inpatient and ambulatory patients.

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

Australia1 site
  • Alfred Health

    Melbourne, Victoria

Other trials in Australia

About this study

Official title: Innovative Use of fungalAi for Antifungal Stewardship in Haematology-oncology Patients

This national Australian study will validate and implement an effective approach to real-time electronic surveillance of fungal infections in patients with blood cancers using technology based on artificial intelligence. It will establish metrics for antifungal stewardship allowing benchmarking of these programs; provide decision support for radiologist interpretation of chest imaging and improve reporting, audit and feedback practices in hospitals where these infections are managed.

Read the detailed description

Invasive fungal diseases (IFD) are rare infections that cause a life-threatening pneumonia in patients with weakened immune systems usually due to cancer chemotherapy and transplantation. Fungal spores are found in air, water and soil making exposure unavoidable in vulnerable patients. In developed countries, molds like Aspergillus are the most challenging type of IFD to diagnose and treat. These infections usually manifest as a culture-negative fungal pneumonia and account for approximately 300K of the 1.9M cases of IFD globally, but estimates are not accurate due to an absence of surveillance systems in hospitals where these infections are managed. Hospitals spend millions on antifungal drugs but are unaware of their patients affected, the effectiveness of their prevention efforts and hospital outbreaks may go unnoticed because surveillance, audit and feedback of fungal infections is not occurring.

Optimising patient outcomes through timely diagnosis and appropriate prescribing of antifungal drugs is the goal of antifungal stewardship programs. Antifungal stewardship is of growing importance to hospitals world-wide because antifungal drugs are few in number, expensive to use and are associated with significant side-effects and drug interactions. Surveillance, audit and feedback are the cornerstones of antifungal stewardship programs that ensure patient care is meeting high standards. However, currently hospitals do not have the mechanisms to detect rare events like fungal infections because it usually presents as a pneumonia buried among hundreds of imaging scans.

"fungalAi™" (fungalAi.com) is a technology based on artificial intelligence (Ai) that uses existing data in hospitals to make real time surveillance of fungal infections possible and assist radiologist interpretation of diagnostic imaging. fungalAi does this through:

  1. Natural language processing, a computational method of understanding human language.
  2. Deep learning based image analysis of diagnostic imaging and
  3. An expert system that integrates clinical data.

What will be the impact?

This project will provide hospitals with the mechanisms for performing real-time surveillance and audit of fungal infections in blood cancer patients through the innovative use of Ai. Strengthening antifungal stewardship through real-time surveillance of fungal diseases will improve patient care by revealing gaps in practice, new patient groups at risk for fungal infections and reduce inappropriate prescribing of antifungal medications through timely audit and feedback. The impact of this project will be:

  1. Improved diagnosis and recognition of fungal infections.
  2. Enhanced prevention.
  3. More appropriate use of antifungal medications.

FungalAi is a scalable technology that will be validated against active manual surveillance of fungal infections in a multi-centre Australian clinical trial. The inclusive approach of fungalAi means that it is of value to many vulnerable patients including neglected groups like children who are included in this project. FungalAi is tuned for detection of fungal pneumonia caused by molds because these infections are more diagnostically challenging than other types of fungal infections. As a result, fungalAi leverages chest computed tomography imaging because it is a critical diagnostic test that is widely available and performed more frequently than invasive tests like lung washings or biopsy. Hence fungalAi natural language processing may miss very rare manifestations like brain infections. Nevertheless, automating detection of fungal pneumonia and improving radiologist recognition of a rare disease using a self-improving system based on neural networks is an important step towards improving the supportive care of patients with cancer. Improving outcomes in cancer is not only about finding a cure. Reducing the impact of infectious threats like fungal diseases is just as important and this can now be achieved by integrating artificial intelligence into patient care.

Being tested
fungalAi platform technology
Keywords
Fungal infections, Deep learning, Electronic surveillance, Antifungal stewardship, Image classification
Medical subject headings
Mycoses

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • fungalAi platform technologyCombination product

    Electronic surveillance and radiologic diagnosis of invasive fungal infections using fungalAi and associated methodologies.

Study groups in NCT03793231
Study groupRoleWhat they receive
Fungal CasesPatients with confirmed invasive fungal infections according to internationally accepted criteria identified by active manual surveillance. Clinical data will be sent to fungalAi platform technology for disease classification.
Receives: Combination Product: fungalAi platform technology
Control patientsPatients without invasive fungal infections.Clinical data will be sent to fungalAi platform technology for disease classification.
Receives: Combination Product: fungalAi platform technology

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Accuracy of electronic surveillance using fungalAi natural language processing compared to active manual methods for detection of fungal pneumonia

    Sensitivity, specificity, ROC, Area under precision-recall curve of Ai assisted surveillance for fungal pneumonia using natural language processing of imaging reports compared to active manual surveillance

    Measured: 12 months

Secondary outcomes (3)
  1. Accuracy of disease classification of deep learning based image analysis for fungal pneumonia at scan level.

    Sensitivity, specificity, ROC of deep learning based image analysis at scan level compared to active manual surveillance.

    Measured: 12 months

  2. Accuracy of feature detection of fungal pneumonia using deep learning based image analysis of chest CT compared to radiologist expertise.

    Sensitivity, error rate (false positives, false negatives) at pixel level of deep learning based image analysis compared to radiologist labels.

    Measured: 12 months

  3. Accuracy of disease classification of an expert system integrating microbiology and antifungal drug prescriptions with text and image analysis compared to active manual surveillance.

    Sensitivity, specificity, ROC, Area under precision-recall curve of Ai assisted surveillance compared to active manual surveillance that will only be performed at Alfred Health.

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Jan 2019
  2. Study start1 Jan 2019
  3. Primary completion30 Dec 2020 (estimated)
  4. Study completion30 Dec 2020 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
1,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03793231
Sponsor's protocol ID
43127/MonH-2018-152967
Other IDs
012018, 2015-54
Acronym
fungalAi
Status last verified
Aug 2020
First submitted
15 Dec 2018
Last updated
23 Oct 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: De-identified individual participant data will be made available in aggregate form for reports, presentations and publications.

Questions about this trial

What is this clinical trial studying?

An observational study of Fungal Infections, run by Bayside Health at 1 site in Australia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 23 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Accuracy of electronic surveillance using fungalAi natural language processing compared to active manual methods for detection of fungal pneumonia (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2020.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in