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

Not yet recruiting

• Conditions: Sepsis; Septic Shock; Bloodstream Infection

• Registration Number: NCT06531031
• Lead Sponsor: Microbio Co Ltd

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 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-07
• Study First Submitted: 2024-07-24
• Study First Submitted QC: 2024-07-28
• Last Update Submitted: 2024-07-28
• Study First Posted: 2024-07-31
• Last Update Posted: 2024-07-31
• Study Start: 2024-11
• Primary Completion: 2025-06
• Study Completion: 2025-08

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 1500

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.
• Single EDTA blood sample collected from one anatomical site.
• EDTA blood sample is stored according to Microbio's stability requirements.
• EDTA blood volume is >1mL.

Exclusion Criteria

• No suspicion of Blood System Infection.
• Any Inclusion Criterion not met.
• Multiple EDTA blood samples from the same patient.
• EDTA blood samples that have not been stored according to Microbio's stability requirements.
• EDTA blood volume <1mL.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Determine the efficacy of detection and identification of the 26-pathogen panel in the InfectID-BSI assay versus standard of care blood culture. Using qPCR - a new molecular technology to identify the top 20 bacterial and 6 yeast sepsis causing species.	Through study completion, an average of 1 year	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. InfectID has it's own reporting software - InfectID-Client which is how the InfectID-BSI results will be reported for the study.
Determine the sensitivity and specificity of InfectID-BSI versus blood culture.	Through study completion, an average of 1 year	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.

Trial Locations

Locations (8)

Indiana University Hospital; 🇺🇸 Indianapolis, Indiana, United States

University of Maryland; 🇺🇸 Baltimore, Maryland, United States

Southwest Regional Laboratory, UK Health Security Agency, Bristol UK; 🇬🇧 Bristol, United Kingdom

Texas Children's Hospital; 🇺🇸 Houston, Texas, United States

The Prince Charles Hospital; 🇦🇺 Chermside, Queensland, Australia

TriCore Reference Laboratories; 🇺🇸 Albuquerque, New Mexico, United States

Vanderbilt University Medical Centre; 🇺🇸 Nashville, Tennessee, United States

The Princess Alexandra Hospital; 🇦🇺 Woolloongabba, Queensland, Australia