Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06531031


Additional trial details provided through ANZCTR are available at the end of this record.


Registration number
NCT06531031
Ethics application status
Date submitted
24/07/2024
Date registered
31/07/2024
Date last updated
31/07/2024

Titles & IDs
Public title
Clinical Performance Study of Microbio InfectID-BSI for Detection of Bacteria and Yeast With Patient Blood Samples
Scientific title
Clinical Performance Study of Microbio InfectID-BSI for Detection of Bacteria and Yeast
Secondary ID [1] 0 0
MB-CLA-PRT-0022
Universal Trial Number (UTN)
Trial acronym
IID-BSIqPCR
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Bloodstream Infection 0 0
Sepsis 0 0
Septic Shock 0 0
Condition category
Condition code
Infection 0 0 0 0
Studies of infection and infectious agents
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Observational [Patient Registry]
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Diagnosis / Prognosis - InfectID-BSI (Bloodstream Infection) qPCR Assay

Diagnosis / Prognosis: InfectID-BSI (Bloodstream Infection) qPCR Assay
InfectID-BSI technology targets nucleic acid sequences unique to the target analyte. The qPCR raw data collected from InfectID-BSI's 9 assay tubes is analysed by Microbio's InfectID-Client (InfectID-BSI-associated software) and the result is reported as an analyte-detection if the unique target analyte is present or no result if the unique target analyte is absent.

InfectID-BSI is carried out with whole blood from a venous puncture (EDTA). DNA is extracted from a sample of the collected blood using a validated DNA extraction instrument according to the manufacturer's instructions. The extracted DNA is then added to the InfectID-BSI qPCR reagent panel which consists of 9 reaction tubes (6 for bacteria, and 3 for yeast species). The panel is subjected to real-time qPCR using a process of Melt Curve analysis using the Rotor-Gene Q MDx qPCR instrument. The assay report identifies the species present in the sample upon completion. Results are generated within 3 hours.
Intervention code [1] 0 0
Diagnosis / Prognosis
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Determine the sensitivity and specificity of InfectID-BSI versus blood culture.
Timepoint [1] 0 0
Through study completion, an average of 1 year
Primary outcome [2] 0 0
Determine the efficacy of detection and identification of the 26-pathogen panel in the InfectID-BSI assay versus standard of care blood culture. Using qPCR - a new molecular technology to identify the top 20 bacterial and 6 yeast sepsis causing species.
Timepoint [2] 0 0
Through study completion, an average of 1 year

Eligibility
Key inclusion criteria
* Male or female of neonates (less than 1 month of age), paediatrics (between 1 month and 17 years of age) or adults (>18 years of age).
* Admitted to ICU, Emergency Department, or other medical wards for acute illness with medical decision to perform blood culture for suspicion of bloodstream Infection.
* Single EDTA blood sample collected from one anatomical site.
* EDTA blood sample is stored according to Microbio's stability requirements.
* EDTA blood volume is >1mL.
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* No suspicion of Blood System Infection.
* Any Inclusion Criterion not met.
* Multiple EDTA blood samples from the same patient.
* EDTA blood samples that have not been stored according to Microbio's stability requirements.
* EDTA blood volume <1mL.

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
1/11/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/08/2025
Actual
Sample size
Target
1500
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
The Prince Charles Hospital - Chermside
Recruitment hospital [2] 0 0
The Princess Alexandra Hospital - Woolloongabba
Recruitment postcode(s) [1] 0 0
4032 - Chermside
Recruitment postcode(s) [2] 0 0
4102 - Woolloongabba
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Indiana
Country [2] 0 0
United States of America
State/province [2] 0 0
Maryland
Country [3] 0 0
United States of America
State/province [3] 0 0
New Mexico
Country [4] 0 0
United States of America
State/province [4] 0 0
Tennessee
Country [5] 0 0
United States of America
State/province [5] 0 0
Texas
Country [6] 0 0
United Kingdom
State/province [6] 0 0
Bristol

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Microbio Co Ltd
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Naomi DeFazio
Address 0 0
Country 0 0
Phone 0 0
+61410661035
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT06531031

Additional trial details provided through ANZCTR
Accrual to date
Recruiting in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 198
Princess Alexandra Hospital
Recruitment hospital [2] 199
The Prince Charles Hospital
Recruitment postcode(s) [1] 198
4102
Recruitment postcode(s) [2] 199
4032
Funding & Sponsors
Funding source category [1] 110
Commercial sector/Industry
Name [1] 110
Microbio Ltd
Address [1] 110
Translational Research Institute - Clinical Research Facility; Office 5.RS.19; Level 5 R Wing; Princess Alexandra Hospital 199 Ipswich Road Woolloongabba QLD 4102
Country [1] 110
Australia
Primary sponsor
Commercial sector/Industry
Primary sponsor name
Microbio Ltd
Primary sponsor address
Translational Research Institute - Clinical Research Facility; Office 5.RS.19; Level 5 R Wing; Princess Alexandra Hospital
199 Ipswich Road
Woolloongabba QLD 4102
Primary sponsor country
Australia
Ethics approval
Ethics application status
Approved
Ethics committee name [1] 80
Metro South Health Human Research Ethics Committee
Address [1] 80
Metro South Research Ethics Committee (EC00167) 199 Ipswich Road Woolloongabba QLD 4102
Country [1] 80
Australia
Date submitted for ethics approval [1] 80
14/02/2024
Approval date [1] 80
25/06/2024
Ethics approval number [1] 80
HREC/2024/QMS/103886
 
Public notes

Contacts
Principal investigator
Title 457 0
Dr
Name 457 0
Flavia Huygens
Address 457 0
Translational Research Institute 199 Ipswich Road Woolloongabba QLD 4102
Country 457 0
Australia
Phone 457 0
0403481612
Fax 457 0
Email 457 0
[email protected]
Contact person for public queries
Title 458 0
Mrs
Name 458 0
Naomi DeFazio
Address 458 0
Translational Research Institute - Clinical Research Facility; Office 5.RS.19; Level 5 R Wing; Princess Alexandra Hospital 199 Ipswich Road
Country 458 0
Australia
Phone 458 0
0410661035
Fax 458 0
Email 458 0
[email protected]
Contact person for scientific queries
Title 459 0
Dr
Name 459 0
Flavia Huygens
Address 459 0
Translational Research Institute 199 Ipswich Road Woolloongabba QLD 4102
Country 459 0
Australia
Phone 459 0
0403481612
Fax 459 0
Email 459 0
[email protected]