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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
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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)
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Secondary ID [1]
312897
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None
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
bloodstream infection
335051
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fungal infection
335052
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Condition category
Condition code
Infection
331562
331562
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0
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Other infectious diseases
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
329473
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Treatment: Devices
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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.
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Control group
Active
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Outcomes
Primary outcome [1]
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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.
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Assessment method [1]
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Comparison and tabulation of InfectID results and routine blood, bronchoalveolar lavage and/or sputum culture results.
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Timepoint [1]
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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.
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Secondary outcome [1]
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Nil
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Assessment method [1]
439387
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Nil
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Timepoint [1]
439387
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Nil
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Eligibility
Key inclusion criteria
1. Patients with suspected BSIs/sepsis and/or invasive fungal infection
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1. Patients with cognitive impairment
2. Patients no suspicion of BSI/sepsis and/or invasive fungal infection
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Study design
Purpose of the study
Diagnosis
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
4/11/2024
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Actual
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Date of last participant enrolment
Anticipated
31/12/2025
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Actual
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Date of last data collection
Anticipated
31/12/2025
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Actual
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Sample size
Target
100
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
QLD
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Recruitment hospital [1]
27069
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The Prince Charles Hospital - Chermside
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Recruitment postcode(s) [1]
43136
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4032 - Chermside
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Funding & Sponsors
Funding source category [1]
317331
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Charities/Societies/Foundations
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Name [1]
317331
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The Common Good/The Prince Charles Hospital Foundation
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Address [1]
317331
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Country [1]
317331
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Australia
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Primary sponsor type
Commercial sector/Industry
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Name
Microbio Ltd
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Address
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
319616
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Address [1]
319616
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Country [1]
319616
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Ethics approval
Ethics application status
Submitted, not yet approved
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Ethics committee name [1]
316063
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Metro North Health Human Research Ethics Committee A
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Ethics committee address [1]
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https://metronorth.health.qld.gov.au/research/ethics-and-governance/human-research-ethics-committee
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
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30/07/2024
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Approval date [1]
316063
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Ethics approval number [1]
316063
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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.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr Flavia Huygens
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Address
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Translational Research Insititute, Level 5 R Wing, The Princess Alexandra Hospital, 199 Ipswich Road, Woolloongabba QLD 4102
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Country
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Australia
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Phone
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+61 403 481 612
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Naomi DeFazio
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Address
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Translational Research Insititute, Level 5 R Wing, The Princess Alexandra Hospital, 199 Ipswich Road, Woolloongabba QLD 4102
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Country
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Australia
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Phone
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+61 410 661 035
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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Flavia Huygens
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Address
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Translational Research Insititute, Level 5 R Wing, The Princess Alexandra Hospital, 199 Ipswich Road, Woolloongabba QLD 4102
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Country
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Australia
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Phone
136656
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+61 403 481 612
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Fax
136656
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Email
136656
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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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
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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.
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