Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624001127594p
Ethics application status
Submitted, not yet approved
Date submitted
4/09/2024
Date registered
18/09/2024
Date last updated
27/10/2024
Date data sharing statement initially provided
18/09/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Clinical Performance Study of Microbio InfectID for detection of bacterial, yeast and fungal pathogens
Scientific title
Clinical Performance Study of Microbio InfectID for detection of bacterial, yeast and fungal pathogens in patients admitted to hospital suspected of having a Blood Stream Infection (BSI)
Secondary ID [1] 312897 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
bloodstream infection 335051 0
fungal infection 335052 0
Condition category
Condition code
Infection 331562 331562 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be included in/consented to participate in the study if they are suspected of having bloodstream infection or fungal infection where an additional study sample will be collected at the same time as routine sample collection. Routine testing will be done with Pathology Queensland and results reported as per their standard pathways. The additional study sample will be tested using the InfectID assay. No results will be provided to the study Investigator in real time, therefore not impacting clinical decision making or clinical treatment. Results will only be provided to investigators once the study is complete. Participants must be enrolled into the study in order for their sample to be tested using Microbio's InfectID assay. Microbio's InfectID assay is a real-time quantitative PCR assay for the most prevalent BSI-causing pathogens (bacteria and yeast) tested directly from whole blood without need for pre-culture.
Participants are required only to donate an additional study sample at the same time as routine samples are being collected. The entire process may take up to 5 minutes to complete. There is no follow up required.
Intervention code [1] 329473 0
Treatment: Devices
Comparator / control treatment
Routine blood, bronchoalveolar lavage and/or sputum samples collected at the same time and tested using routine pathology equipment in Pathology Queensland at The Prince Charles Hospital. The additional sample/s collected will be tested at Microbio's laboratory using the InfectID assay.
Control group
Active

Outcomes
Primary outcome [1] 339296 0
Assess the specificity and sensitivity of InfectID assay in identifying bacterial, yeast and fungal pathogens. This assessment will be a composite outcome for InfectID assay.
Timepoint [1] 339296 0
Routine and study blood, bronchoalveolar lavage and/or sputum sample collection will occur as determined by the study Investigator. The routine sample results will be delivered to the study investigator as per hospital and laboratory guidelines. The InfectID testing will be conducted in Microbio's laboratory and the result will only be compared to the routine sample results once all study samples have been collected and the study has concluded.
Secondary outcome [1] 439387 0
Nil
Timepoint [1] 439387 0
Nil

Eligibility
Key inclusion criteria
1. Patients with suspected BSIs/sepsis and/or invasive fungal infection
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Patients with cognitive impairment
2. Patients no suspicion of BSI/sepsis and/or invasive fungal infection

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
4/11/2024
Actual
Date of last participant enrolment
Anticipated
31/12/2025
Actual
Date of last data collection
Anticipated
31/12/2025
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 27069 0
The Prince Charles Hospital - Chermside
Recruitment postcode(s) [1] 43136 0
4032 - Chermside

Funding & Sponsors
Funding source category [1] 317331 0
Charities/Societies/Foundations
Name [1] 317331 0
The Common Good/The Prince Charles Hospital Foundation
Country [1] 317331 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Microbio Ltd
Address
Country
Australia
Secondary sponsor category [1] 319616 0
None
Name [1] 319616 0
Address [1] 319616 0
Country [1] 319616 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 316063 0
Metro North Health Human Research Ethics Committee A
Ethics committee address [1] 316063 0
https://metronorth.health.qld.gov.au/research/ethics-and-governance/human-research-ethics-committee
Ethics committee country [1] 316063 0
Australia
Date submitted for ethics approval [1] 316063 0
30/07/2024
Approval date [1] 316063 0
Ethics approval number [1] 316063 0

Summary
Brief summary
The study is designed to identify patients from different hospital departments who have been admitted to the Transplant unit, the ICU and/or Outpatients Department, suspected of having a Blood Stream Infection (BSI) and/or an invasive fungal infection. Clinical assessment of patients eligible to be enrolled in this study will be conducted by the department physicians. Study subjects will have blood samples collected for blood culture (standard of care/SOC), as well as an additional blood EDTA tube, and/or bronchiolar lavage and/or sputum samples collected at the same time. These samples will be processed using the Microbio InfectID assay in an experienced diagnostic laboratory. Diagnostic accuracy will be calculated with respect to the SOC blood culture and other culture-based test results.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 136654 0
Dr Flavia Huygens
Address 136654 0
Translational Research Insititute, Level 5 R Wing, The Princess Alexandra Hospital, 199 Ipswich Road, Woolloongabba QLD 4102
Country 136654 0
Australia
Phone 136654 0
+61 403 481 612
Fax 136654 0
Email 136654 0
[email protected]
Contact person for public queries
Name 136655 0
Naomi DeFazio
Address 136655 0
Translational Research Insititute, Level 5 R Wing, The Princess Alexandra Hospital, 199 Ipswich Road, Woolloongabba QLD 4102
Country 136655 0
Australia
Phone 136655 0
+61 410 661 035
Fax 136655 0
Email 136655 0
[email protected]
Contact person for scientific queries
Name 136656 0
Flavia Huygens
Address 136656 0
Translational Research Insititute, Level 5 R Wing, The Princess Alexandra Hospital, 199 Ipswich Road, Woolloongabba QLD 4102
Country 136656 0
Australia
Phone 136656 0
+61 403 481 612
Fax 136656 0
Email 136656 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
No individual results will be made available. It will only be comparison results between InfectID and other routine culture samples


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.