Bloodstream InfectionIID-BSIqPCRNCT06531031
Clinical Performance Study of Microbio InfectID-BSI for Detection of Bacteria and Yeast With Patient Blood Samples
An observational study of Bloodstream Infection and Sepsis, run by Microbio Co Ltd at 8 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Bloodstream Infection, Sepsis, Septic Shock
- What is being tested?
- InfectID-BSI (Bloodstream Infection) qPCR Assay
- How many people
- 1,500 participants
- Where
- 8 sitesin 3 countries
- Study dates
- Nov 2026to Jan 2028
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Child, Adult, Older adult
Study population: The study seeks to enroll neonates (less than 1 month of age), pediatrics (between 1 month and 17 years of age) and adults (>18 years of age) who are suspected to have a blood stream infection (BSI /Sepsis).
Who may be able to join
- 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.
- Two additional EDTA blood sample/s collected from one anatomical site and at the same time as blood culture (two EDTA samples to be collected where possible).
- EDTA blood volume is ≥1mL.
- EDTA blood sample is stored according to Microbio's stability requirements.
Who cannot join
- No suspicion of blood stream infection (BSI).
- Any inclusion criterion not met.
- Multiple EDTA blood samples from the same patient.
- EDTA blood sample not obtained from the same anatomical site and at the same time as the blood culture sample.
- Subject has had an antimicrobial drug administered through the same port or central line as is used to collect the specimen.
- EDTA blood samples that have not been stored according to Microbio's sample stability requirements.
- EDTA blood volume <1mL.
Trial locations and contacts
8 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
8 sites in 3 countries
United States5 sites
TriCore Reference Laboratories
Albuquerque, New Mexico, 87102
Naomi DeFazio, 5059388888, ndefazio@microbio.com.au
University of Maryland
Baltimore, Maryland, 21201
Naomi DeFazio, 4107063100, ndefazio@microbio.com.au
Texas Children's Hospital
Houston, Texas, 77030
Indiana University Hospital
Indianapolis, Indiana, 46202
Naomi DeFazio, 3179445000, ndefazio@microbio.com.au
Vanderbilt University Medical Centre
Nashville, Tennessee, 37232
Naomi DeFazio, 6153225000, ndefazio@microbio.com.au
Australia2 sites
The Prince Charles Hospital
Chermside, Queensland, 4032
Naomi DeFazio, +61410661035, ndefazio@microbio.com.au
The Princess Alexandra Hospital
Woolloongabba, Queensland, 4102
Naomi DeFazio, +61410661035, ndefazio@microbio.com.au
United Kingdom1 site
Southwest Regional Laboratory, UK Health Security Agency, Bristol UK
Bristol
Naomi DeFazio, +61410661035, ndefazio@microbio.com.au
About this study
Official title: Clinical Performance Study of Microbio InfectID-BSI for Detection of Bacteria and Yeast
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.
- Conditions
- Bloodstream Infection, Sepsis, Septic Shock
- Being tested
- InfectID-BSI (Bloodstream Infection) qPCR Assay
- Medical subject headings
- Sepsis, Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InfectID-BSI (Bloodstream Infection) qPCR AssayDiagnostic test
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the sensitivity and specificity of InfectID-BSI versus 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.
Measured: Through study completion, an average of 1 year
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.
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. InfectID has it's own reporting software - InfectID-Client which is how the InfectID-BSI results will be reported for the study.
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2024
- Study startNov 2026 (estimated)
- Primary completionJan 2028 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bloodstream InfectionStudies 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
- Cross-sectional
- Enrolment
- 1,500 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Microbio Co Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06531031
- Sponsor's protocol ID
- MB-CLA-PRT-0022
- Acronym
- IID-BSIqPCR
- Status last verified
- Oct 2026
- First submitted
- 24 Jul 2024
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Performance Study of Microbio InfectID-BSI for Detection of Bacteria and Yeast
- ClinicalTrials.gov ID
- NCT06531031
- Acronym / sponsor ID
- IID-BSIqPCR / MB-CLA-PRT-0022
- Conditions
- Bloodstream Infection, Sepsis, Septic Shock
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Microbio Co LtdIndustry (pharma, biotech, devices)
- Study start
- Nov 2026 (estimated)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 31 Jul 2024 (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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study seeks to enroll neonates (less than 1 month of age), pediatrics (between 1 month and 17 years of age) and adults (>18 years of age) who are suspected to have a blood stream infection (BSI /Sepsis).
Key inclusion criteria (5 listed)
- 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.
- Two additional EDTA blood sample/s collected from one anatomical site and at the same time as blood culture (two EDTA samples to be collected where possible).
- EDTA blood volume is ≥1mL.
- EDTA blood sample is stored according to Microbio's stability requirements.
Key exclusion criteria (7 listed)
- No suspicion of blood stream infection (BSI).
- Any inclusion criterion not met.
- Multiple EDTA blood samples from the same patient.
- EDTA blood sample not obtained from the same anatomical site and at the same time as the blood culture sample.
- Subject has had an antimicrobial drug administered through the same port or central line as is used to collect the specimen.
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 |
|---|---|---|
| InfectID-BSI (Bloodstream Infection) qPCR AssayInfectID-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. | Diagnostic test | – |
Primary outcome
Determine the sensitivity and specificity of InfectID-BSI versus blood culture.
Time frame: Through study completion, an average of 1 year
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.
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.
Time frame: Through study completion, an average of 1 year
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. InfectID has it's own reporting software - InfectID-Client which is how the InfectID-BSI results will be reported for the study.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2026.
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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.
8 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bloodstream Infection and Sepsis, run by Microbio Co Ltd at 8 sites in 3 countries.
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 5 inclusion and 7 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: opening soon, as of the sponsor's last update on 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States, Australia, United Kingdom. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Naomi DeFazio (+61410661035, NDeFazio@microbio.com.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine the sensitivity and specificity of InfectID-BSI versus blood culture. (time frame: Through study completion, an average of 1 year). The study lists 2 primary outcomes in all. 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 8 Oct 2026.