Status:
NOT_YET_RECRUITING
Clinical Performance Study of Microbio InfectID-BSI for Detection of Bacteria and Yeast With Patient Blood Samples
Lead Sponsor:
Microbio Co Ltd
Conditions:
Bloodstream Infection
Sepsis
Eligibility:
All Genders
Brief Summary
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 v...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
November 1 2026
Estimated Enrollment :
1500 Patients enrolled
Trial Details
Trial ID
NCT06531031
Start Date
August 1 2025
End Date
November 1 2026
Last Update
July 24 2025
Active Locations (8)
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1
Indiana University Hospital
Indianapolis, Indiana, United States, 46202
2
University of Maryland
Baltimore, Maryland, United States, 21201
3
TriCore Reference Laboratories
Albuquerque, New Mexico, United States, 87102
4
Vanderbilt University Medical Centre
Nashville, Tennessee, United States, 37232