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BacteremiaNCT04821661

T2 and SeptiCyte RAPID Duration Project

An observational study of Bacteremia, run by The University of Queensland at 3 sites in Australia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Infection with bacteria and other germs in the blood can be deadly. How long germs stay in the blood is important for two reasons. The first is that if they stay in the blood for many days it is a sign that antibiotics may need to be changed. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Bacteremia
How many people
102 participants
Where
3 sitesAustralia
Study dates
11 Jan 2022to 30 Apr 2023
Phase
Observational
Are there results?
None posted in the registry

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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients at the Royal Brisbane and Women's Hospital, Caboolture Hospital and Redcliffe Hospital who have bacteria or yeast in the blood identified by the MALDI-TOF MS and Gram stain respectively

Who may be able to join

  • Patients who have proven bloodstream infection with any T2-on panel pathogen (Enterococcus faecium, S. aureus, Klebsiella pneumoniae, Acinetobacter baumannii, Pseudomonas aeruginosa, Escherichia coli and Candida spp.)

Who cannot join

  • Palliative care approach
  • Failure to give written informed consent (by patient or their legal representative)
  • Polymicrobial index blood culture

Trial locations and contacts

3 sites in 1 country.

Australia3 sites

  • Caboolture Hospital

    Brisbane, Queensland

  • Redcliffe Hospital

    Brisbane, Queensland

  • Royal Brisbane and Women's Hospital

    Brisbane, Queensland

Other trials in Australia

About this study

Official title: Duration of Bloodstream Infection as Measured by Conventional Cultures Compared With Novel Culture Independent Systems and Persistence of Biomarkers Associated With Severe Infection

Infection with bacteria and other germs in the blood can be deadly. How long germs stay in the blood is important for two reasons. The first is that if they stay in the blood for many days it is a sign that antibiotics may need to be changed. The second is that if they stay in the blood for only a short time it may give doctors confidence to switch to tablets and consider early discharge from hospital. This study is evaluating the diagnostic and prognostic performance of two novel technologies when used to measure the duration of the bloodstream infection.

Read the detailed description

Bloodstream infection is highly significant and is associated with mortality rates of between 10 and 25%.

For some infection types (for example, Staphylococcus aureus) a longer duration of bacteria being present in the blood is linked to higher mortality. With traditional microbiologic techniques, bloodstream infection with gram-negative bacteria is usually quite brief. However, new culture independent bacteraemia detection systems (such as T2 magnetic resonance assay) are more sensitive than traditional blood culture systems and may show that gram-negative bacteraemia is more prolonged in some patients than has previously been thought. This observational study will investigate the correlation between the duration of bloodstream infection by mean of traditional blood culture techniques with:

  1. Duration of the bloodstream infection by mean of the T2 magnetic resonance assay, a new culture independent bacteraemia detection system.
  2. Persistence of inflammation as measured by the SeptiCyte RAPID test, a host response assay able to differentiate infectious from sterile inflammation.

The study will also correlate each measure of the duration of bacteraemia with microbiological and clinical outcomes.

Conditions
Bacteremia
Keywords
Bacteraemia, Gram-negative Bacteremia, Bacterial Infections, T2 magnetic resonance assay, SeptiCyte RAPID
Medical subject headings
Bacteremia, Toxemia, Bacterial Infections

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Duration of bloodstream infection measured by conventional blood cultures and the T2 magnetic resonance assay

    The T2 system is a new diagnostic detection method utilizing miniaturized magnetic resonance technology. The T2 system has been shown to quickly and accurately identify molecular targets within patient samples without the need for purification or extraction of target molecules from the sample. It does not require bacterial culture and can detect organisms as low as 1 CFU/mL in whole blood. The study will compare the duration of detectable pathogens in the bloodstream as measured by the T2 with the duration of bloodstream infection according to conventional cultures

    Measured: Days 1-4

  2. Persistent infection defined as metastatic infection and lack of source control

    The study will explore the correlation between the duration of detectable pathogens in the bloodstream as measured by the T2 (duration of T2emia) and the presence of persistent infection

    Measured: Days 1-4

Secondary outcomes (3)

  1. Short-term clinical outcome (SOFA success)

    The study will explore the correlation between the duration of detectable pathogens in the bloodstream as measured by the T2 (duration of T2emia) and short-term clinical outcome. A "successful short-term outcome" or "SOFA success" is defined as survival for the first 7 days from BSI onset with a stable or decreased Sequential Organ Failure Assessment (SOFA) score (for ICU patients) or modified SOFA score (for non-ICU patients), defined as follows: if the baseline SOFA/mSOFA >=3, a decrease of at least 30% in that score, if the baseline SOFA/mSOFA <3, a stable or decreased SOFA/mSOFA score. Patients discharged before day 7 will be assumed to have improved SOFA scores. The lack of "SOFA success" will be defined "SOFA failure".

    Measured: Days 1-7

  2. Long-term clinical outcome

    The study will explore the correlation between the duration of detectable pathogens in the bloodstream as measured by the T2 (duration of T2emia) and long-term clinical outcomes. A "successful long-term outcome" is defined as survival for the first 6 months from the BSI onset and maintenance of the baseline functional performance status defined by the functional bloodstream infection score (FBIS) score 7 days prior to the BSI onset.

    Measured: 6-months from the index BSI

  3. Persistent infection

    SeptiCyte is a host-response assay able to differentiate infectious from sterile inflammation by providing a score (SeptiScore) from 1-15. It is approved for the diagnosis of sepsis in ICU patients. Whether SeptiScore may have a role in diagnosing the persistence of the infection in patients with proven BSI is unknown. The study will explore the performance of SeptiScore in diagnosing persistent infection including persistent BSI and metastatic infection

    Measured: Day 1-4

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Mar 2021
  2. Study start11 Jan 2022
  3. Primary completion31 Mar 2023
  4. Study completion30 Apr 2023

Resources

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
Case only
Time perspective
Cross-sectional
Enrolment
102 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04821661
Sponsor's protocol ID
HREC/2021/QRBW/70126
Status last verified
Apr 2025
First submitted
17 Mar 2021
Last updated
1 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Bacteremia, run by The University of Queensland at 3 sites in Australia.

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 1 inclusion and 3 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: finished, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Australia. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Duration of bloodstream infection measured by conventional blood cultures and the T2 magnetic resonance assay (time frame: Days 1-4). 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?

On the ClinicalTrials.gov record for NCT04821661.

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 1 May 2026.

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