T2 and SeptiCyte RAPID Duration Project

NCT04821661 | Completed

• 1 other identifier: HREC/2021/QRBW/70126
• Study Type: observational
• Target: 102
• Locations: 1 country
• Sites: 3

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.

Conditions

Bacteremia

Keywords

Bacteraemia; Gram-negative Bacteremia; Bacterial Infections; T2 magnetic resonance assay; SeptiCyte RAPID

Outcome Measures

Primary Outcomes (2)

• 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

  Days 1-4

• 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

  Days 1-4

Secondary Outcomes (3)

• Short-term clinical outcome (SOFA success)

  Days 1-7

• Long-term clinical outcome

  6-months from the index BSI

• Persistent infection

  Day 1-4

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.)

You may not qualify if:

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

Sponsors & Collaborators

• The University of Queensland: lead
• Metro North Hospital and Health Service: collaborator
• Pathology Queensland: collaborator

Study Sites (3)

Caboolture Hospital

Brisbane, Queensland, Australia

Location

Redcliffe Hospital

Brisbane, Queensland, Australia

Location

Royal Brisbane and Women's Hospital

Brisbane, Queensland, Australia

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood

MeSH Terms

Conditions

Bacteremia; Toxemia; Bacterial Infections

Condition Hierarchy (Ancestors)

Bacterial Infections and Mycoses; Infections; Sepsis; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 17, 2021
• First Posted: March 29, 2021
• Study Start: January 11, 2022
• Primary Completion: March 31, 2023
• Study Completion: April 30, 2023
• Last Updated: May 1, 2026

Record last verified: 2025-04

Locations

AU (3)