Fungal InfectionsfungalAiNCT03793231
fungalAi for Fungal Surveillance & Antifungal Stewardship
An observational study of Fungal Infections, run by Bayside Health at 1 site in Australia.
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.
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:
- Natural language processing, a computational method of understanding human language.
- Deep learning based image analysis of diagnostic imaging and
- 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:
- Improved diagnosis and recognition of fungal infections.
- Enhanced prevention.
- 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.
- Conditions
- Fungal Infections
- 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 group | Role | What they receive |
|---|---|---|
| Fungal Cases | Patients 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 patients | Patients 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.
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)
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
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
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.
- First posted4 Jan 2019
- Study start1 Jan 2019
- Primary completion30 Dec 2020 (estimated)
- Study completion30 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fungal InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Bayside Health
- Sponsor type
- Other government
- Collaborators
- Monash University, Monash Health, Eastern Health, Western Sydney Local Health District, SA Health, Fremantle Hospital and Health Service, Singhealth Foundation
- Responsible party
- Sponsor
- Investigators
- Michelle Dr Ananda-Rajah, Principal investigator, The Alfred
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.
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Innovative Use of fungalAi for Antifungal Stewardship in Haematology-oncology Patients
- ClinicalTrials.gov ID
- NCT03793231
- Acronym / sponsor ID
- fungalAi / 43127/MonH-2018-152967
- Conditions
- Fungal Infections
- Keywords
- Fungal infections, Deep learning, Electronic surveillance, Antifungal stewardship, Image classification
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Bayside HealthOther government
- Collaborators
- Monash University, Monash Health, Eastern Health, Western Sydney Local Health District, SA Health, Fremantle Hospital and Health Service, Singhealth Foundation
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 30 Dec 2020 (estimated)
- Study completion
- 30 Dec 2020 (estimated)
- First posted
- 4 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- Natural language processing, a computational method of understanding human language.
- Deep learning based image analysis of diagnostic imaging and
- 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:
- Improved diagnosis and recognition of fungal infections.
- Enhanced prevention.
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fungal Cases | – | Combination Product: fungalAi platform technologyPatients 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. |
| Control patients | – | Combination Product: fungalAi platform technologyPatients without invasive fungal infections.Clinical data will be sent to fungalAi platform technology for disease classification. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- 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.
Key inclusion criteria (3 listed)
- Adults and children
- Under the haematology service at participating sites
- Inpatient and ambulatory patients.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| fungalAi platform technologyElectronic surveillance and radiologic diagnosis of invasive fungal infections using fungalAi and associated methodologies. | Combination product | Control patients, Fungal Cases |
Primary outcome
Accuracy of electronic surveillance using fungalAi natural language processing compared to active manual methods for detection of fungal pneumonia
Time frame: 12 months
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
3 secondary outcomes
Accuracy of disease classification of deep learning based image analysis for fungal pneumonia at scan level.
Time frame: 12 months
Accuracy of feature detection of fungal pneumonia using deep learning based image analysis of chest CT compared to radiologist expertise.
Time frame: 12 months
Accuracy of disease classification of an expert system integrating microbiology and antifungal drug prescriptions with text and image analysis compared to active manual surveillance.
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2020.
- Individual participant dataSharing planned: Yes. De-identified individual participant data will be made available in aggregate form for reports, presentations and publications.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michelle Dr Ananda-Rajah principal investigator
The Alfred
1 site in 1 country: see every site and its status.
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.