None listed
Conditions
Brief summary
The study is designed to identify patients from different hospital departments who have been admitted to the Transplant unit, the ICU and/or Outpatients Department, suspected of having a Blood Stream Infection (BSI) and/or an invasive fungal infection. Clinical assessment of patients eligible to be enrolled in this study will be conducted by the department physicians. Study subjects will have blood samples collected for blood culture (standard of care/SOC), as well as an additional blood EDTA tube, and/or bronchiolar lavage and/or sputum samples collected at the same time. These samples will be processed using the Microbio InfectID assay in an experienced diagnostic laboratory. Diagnostic accuracy will be calculated with respect to the SOC blood culture and other culture-based test results.
Interventions
Participants will be included in/consented to participate in the study if they are suspected of having bloodstream infection or fungal infection where an additional study sample will be collected at the same time as routine sample collection. Routine testing will be done with Pathology Queensland and results reported as per their standard pathways. The additional study sample will be tested using the InfectID assay. No results will be provided to the study Investigator in real time, therefore no
Participants will be included in/consented to participate in the study if they are suspected of having bloodstream infection or fungal infection where an additional study sample will be collected at the same time as routine sample collection. Routine testing will be done with Pathology Queensland and results reported as per their standard pathways. The additional study sample will be tested using the InfectID assay. No results will be provided to the study Investigator in real time, therefore not impacting clinical decision making or clinical treatment. Results will only be provided to investigators once the study is complete. Participants must be enrolled into the study in order for their sample to be tested using Microbio's InfectID assay. Microbio's InfectID assay is a real-time quantitative PCR assay for the most prevalent BSI-causing pathogens (bacteria and yeast) tested directly from whole blood without need for pre-culture. Participants are required only to donate an additional study sample at the same time as routine samples are being collected. The entire process may take up to 5 minutes to complete. There is no follow up required.
Sponsors
Microbio Ltd
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Diagnosis
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients with suspected BSIs/sepsis and/or invasive fungal infection
Exclusion criteria
1. Patients with cognitive impairment 2. Patients no suspicion of BSI/sepsis and/or invasive fungal infection
Outcome results
None listed