Language: BG BG
← Back to results
Not yet recruiting NCT06531031

Clinical Performance Study of Microbio InfectID-BSI for Detection of Bacteria and Yeast With Patient Blood Samples

Conditions: Bloodstream Infection Sepsis Septic Shock

Sponsor: Microbio Co Ltd

trial.available_in: БГ
Overview
The objective of the study is to determine the efficacy of the Microbio InfectID-BSI qPCR kit in a clinical laboratory environment using patient whole blood for pathogen detection and identification versus standard of care methods from blood culture. The objective of this study is to determine the sensitivity and specificity of the Microbio InfectID-BSI qPCR kit by the evaluation of clinical blood samples versus standard of care methods from blood culture.
Who can participate
Inclusion Criteria: * Male or female of neonates (less than 1 month of age), paediatrics (between 1 month and 17 years of age) or adults (≥18 years of age). * Admitted to ICU, Emergency Department, or other medical wards for acute illness with medical decision to perform blood culture for suspicion of bloodstream Infection. * Two additional EDTA blood sample/s collected from one anatomical site and at the same time as blood culture (two EDTA samples to be collected where possible). * EDTA blood volume is ≥1mL. * EDTA blood sample is stored according to Microbio's stability requirements. Exclusion Criteria: * No suspicion of blood stream infection (BSI). * Any inclusion criterion not met. * Multiple EDTA blood samples from the same patient. * EDTA blood sample not obtained from the same anatomical site and at the same time as the blood culture sample. * Subject has had an antimicrobial drug administered through the same port or central line as is used to collect the specimen. * EDTA blood samples that have not been stored according to Microbio's sample stability requirements. * EDTA blood volume \<1mL.
Locations 3
Australia (1)
The Prince Charles Hospital
Chermside , Queensland
United Kingdom (1)
Southwest Regional Laboratory, UK Health Security Agency, Bristol UK
Bristol
United States (1)
Indiana University Hospital
Indianapolis , Indiana
Technical details
Status
Not yet recruiting
Study type
OBSERVATIONAL
Sex
Male and female
Healthy volunteers
No
Start date
01.08.2025
Completion date
01.11.2026
Registry ID
NCT06531031
Source
anzctr
trial.inquiry_btn

Information is automatically extracted from ClinicalTrials.gov. Consult your doctor before taking action.