Ignite Creation Date:
2025-12-24 @ 12:37 PM
Ignite Modification Date:
2026-02-22 @ 3:56 PM
Study NCT ID:
NCT04821661
Status:
UNKNOWN
Last Update Posted:
2023-08-08
First Post:
2021-03-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
T2 and SeptiCyte RAPID Duration Project
Sponsor:
The University of Queensland
Organization:
Study Overview
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
Status:
UNKNOWN
Status Verified Date:
2023-08
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: