Not yet recruitingOBSERVATIONAL

Clinical Performance Study of Microbio InfectID-BSI for Detection of Bacteria and Yeast With Patient Blood Samples

This study is about a new way to quickly find serious infections, like sepsis, in the blood. These infections are caused by germs like bacteria or yeast. The new test is called Microbio InfectID-BSI and it uses a special technology called qPCR. Doctors normally send a blood sample to grow these germs, which can take time. This study wants to see if the new InfectID-BSI test can find these germs faster and just as accurately, using a small blood sample taken at the same time as the usual tests. We're checking how well it works in hospitals when people are suspected of having a bloodstream infection. The goal is to see if this new test could help doctors get results more quickly to treat patients effectively.

At a glance

Status

Not yet recruiting

Sponsor

Microbio Co Ltd

Enrolment target

1,500

Start

01 Aug 2025

Estimated completion

01 Nov 2026

Bloodstream Infection Sepsis Septic Shock

What is this study about?

This study is testing a new method called Microbio InfectID-BSI. This new test aims to quickly find out if there are harmful bacteria or yeast in a person's blood. These types of infections can be very serious, sometimes leading to conditions like sepsis, which is when the body's reaction to an infection damages its own tissues and organs. Currently, to find these germs, doctors usually take a blood sample and send it to a lab to try and grow the germs. This 'blood culture' process can take a day or even more to get results.

The new InfectID-BSI test uses a different approach. It works by looking for tiny pieces of genetic material from bacteria or yeast directly in the blood. This could potentially give doctors results much faster. The main goal of this study is to compare how well this new test works against the usual blood culture tests. Researchers will be looking at whether the new test can accurately find the germs when they are present and correctly show when they are not.

Finding serious infections in the blood quickly is very important because it allows doctors to start the right treatment sooner. This study aims to see if the Microbio InfectID-BSI test could be a helpful tool in hospitals to get faster answers, which could improve how people with these serious infections are cared for. It's about finding better and quicker ways to help patients when they are very unwell with suspected bloodstream infections.

Key takeaways

Tests a new method for quickly finding blood infections (like sepsis).
Uses a small, extra blood sample taken during your routine blood draw.
Aims to compare this new test with current standard methods.
Your participation may help improve future patient care.
Does not affect your treatment or involve new medication.

Who may be eligible?

To join this study, you need to be in the hospital – this could be in the Emergency Department, an intensive care unit (ICU), or on a general ward – because doctors suspect you have a serious infection in your blood, called a bloodstream infection. This means that a doctor has already decided to take a blood sample to check for such an infection.

You can be any age, from a newborn baby to an older adult. When the doctor takes the usual blood sample to check for infection, they would also need to take a small extra blood sample at the same time and from the same place. This extra blood sample helps the researchers test the new method.

You wouldn't be able to join the study if doctors aren't concerned about a bloodstream infection, or if the extra blood sample isn't taken properly, for example, if it's too small or not kept at the right temperature. Also, if antibiotics were given through the same tube used to take the blood sample, you might not be able to participate.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you in the hospital due to an acute illness?
Has your doctor decided to take a blood sample to check for a bloodstream infection?
Could an extra small blood sample be taken at the same time as your usual blood test?
Have you ensured that antibiotics haven't been given through the same tube used for your blood sample?

Answer every question to see your result.

What does participation involve?

If you are asked to take part in this study, it simply involves providing a small extra blood sample. This sample will be taken at the very same time and from the same spot as your usual blood sample that your doctors need to check for infection. There are no additional hospital visits or special assessments required for this study. You won't be given any new medication as part of the study itself. After the blood sample is collected, there is no further involvement required from you. The researchers will then use this sample in the lab to test the new InfectID-BSI method, comparing it with your routine test results. The study will not affect your treatment plan, which will be based on your doctor's usual care.

Potential risks and benefits

Since this study only involves taking a small extra blood sample at the same time as your routine blood tests, there are very few added risks. The small discomfort of the blood draw is already part of the standard care you are receiving. There are no direct benefits to you as an individual for taking part, as the results of the new test will not be used to manage your care during this study. However, your participation could help researchers learn more about new ways to quickly find serious infections, potentially helping many people in the future. Remember, taking part in any study is entirely voluntary, and you have the right to withdraw at any time without it affecting your medical care.

Locations (8)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Indiana University Hospital
Verified postcode
Indianapolis, United States
University of Maryland
Verified postcode
Baltimore, United States
TriCore Reference Laboratories
Verified postcode
Albuquerque, United States
Vanderbilt University Medical Centre
Verified postcode
Nashville, United States
Texas Children's Hospital
Verified postcode
Houston, United States
The Prince Charles Hospital
Verified postcode
Chermside, Australia
The Princess Alexandra Hospital
Verified postcode
Woolloongabba, Australia
Southwest Regional Laboratory, UK Health Security Agency, Bristol UK
Verified postcode
Bristol, United Kingdom

Common questions

What is a bloodstream infection?

It's when harmful germs like bacteria or yeast get into your blood, which can make you very unwell.

What is sepsis?

Sepsis is a serious condition where your body's reaction to an infection damages its own organs and tissues.

Will the new test affect my treatment?

No, your doctors will continue to treat you based on their usual methods. The new test is just for research.

Will I get my test results?

The results from the research test will not be shared with you or your doctor during your care, as this is a study to see if the test works.

Is the new test safe?

The test itself is done on a blood sample in a lab, so it doesn't involve any direct treatment being given to you.

How to find out more

Naomi DeFazio

NDeFazio@microbio.com.au +61410661035 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.