- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04821661
T2 and SeptiCyte RAPID Duration Project
Duration of Bloodstream Infection as Measured by Conventional Cultures Compared With Novel Culture Independent Systems and Persistence of Biomarkers Associated With Severe Infection
Study Overview
Status
Conditions
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:
- Duration of the bloodstream infection by mean of the T2 magnetic resonance assay, a new culture independent bacteraemia detection system.
- 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 Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Tiffany Harris-Brown
- Phone Number: +61 7 3346 6072
- Email: t.harrisbrown@uq.edu.au
Study Locations
-
-
Queensland
-
Brisbane, Queensland, Australia
- Recruiting
- Royal Brisbane and Women's Hospital
-
Contact:
- Hugh Wright
-
Brisbane, Queensland, Australia
- Not yet recruiting
- Caboolture Hospital
-
Contact:
- Kevin O'Callaghan
-
Brisbane, Queensland, Australia
- Not yet recruiting
- Redcliffe Hospital
-
Contact:
- Nastaran Rafiei
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Duration of bloodstream infection measured by conventional blood cultures and the T2 magnetic resonance assay
Time Frame: Days 1-4
|
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
|
Days 1-4
|
Persistent infection defined as metastatic infection and lack of source control
Time Frame: Days 1-4
|
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
|
Days 1-4
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Short-term clinical outcome (SOFA success)
Time Frame: Days 1-7
|
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".
|
Days 1-7
|
Long-term clinical outcome
Time Frame: 6-months from the index BSI
|
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.
|
6-months from the index BSI
|
Persistent infection
Time Frame: Day 1-4
|
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
|
Day 1-4
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HREC/2021/QRBW/70126
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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