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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
The objective of the study is to determine the efficacy of the Microbio InfectID-BSI qPCR kit in a clinical laboratory environment using patient whole blood for pathogen detection and identification versus standard of care methods from blood culture.

The objective of this study is to determine the sensitivity and specificity of the Microbio InfectID-BSI qPCR kit by the evaluation of clinical blood samples versus standard of care methods from blood culture.
Trial website
https://clinicaltrials.gov/study/NCT06531031
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



Summary Results

For IPD and results data, please see 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]