Clinical trial NCT04821661: T2 and SeptiCyte RAPID Duration Project
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Bacteremia
Keywords: Bacteraemia
Gram-negative Bacteremia
Bacterial Infections
T2 magnetic resonance assay
SeptiCyte RAPID
Lead sponsor: The University of Queensland
Sponsor class: OTHER
Collaborators: name: Metro North Hospital and Health Service
name: Pathology Queensland
First posted: 2021-03-29
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
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

Brief 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. 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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.)

Exclusion Criteria:

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

Primary outcomes:
measure: Duration of bloodstream infection measured by conventional blood cultures and the T2 magnetic resonance assay
timeFrame: Days 1-4
measure: Persistent infection defined as metastatic infection and lack of source control
timeFrame: Days 1-4
Secondary outcomes:
measure: Short-term clinical outcome (SOFA success)
timeFrame: Days 1-7
measure: Long-term clinical outcome
timeFrame: 6-months from the index BSI
measure: Persistent infection
timeFrame: Day 1-4
Other outcomes:
Locations:
city: Brisbane
country: Australia
facility: Caboolture Hospital
state: Queensland
city: Brisbane
country: Australia
facility: Redcliffe Hospital
state: Queensland
city: Brisbane
country: Australia
facility: Royal Brisbane and Women's Hospital
state: Queensland
Study officials:
References: