T2 and SeptiCyte RAPID Duration Project

NCT ID: NCT04821661

Last Updated: 2023-08-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-01-11

Study Completion Date

2023-08-31

Brief Summary

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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

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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

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Bacteremia

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Metro North Hospital and Health Service

UNKNOWN

Sponsor Role collaborator

Pathology Queensland

UNKNOWN

Sponsor Role collaborator

The University of Queensland

OTHER

Sponsor Role lead

Responsible Party

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Professor David L. Paterson

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Caboolture Hospital

Brisbane, Queensland, Australia

Site Status NOT_YET_RECRUITING

Redcliffe Hospital

Brisbane, Queensland, Australia

Site Status NOT_YET_RECRUITING

Royal Brisbane and Women's Hospital

Brisbane, Queensland, Australia

Site Status RECRUITING

Countries

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Australia

Central Contacts

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Tiffany Harris-Brown

Role: CONTACT

+61 7 3346 6072

Facility Contacts

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Kevin O'Callaghan

Role: primary

Nastaran Rafiei

Role: primary

Hugh Wright

Role: primary

Other Identifiers

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HREC/2021/QRBW/70126

Identifier Type: -

Identifier Source: org_study_id

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