Clinical trial NCT06531031: Clinical Performance Study of Microbio InfectID-BSI for Detection of Bacteria and Yeast With Patient Blood Samples
Official title: Clinical Performance Study of Microbio InfectID-BSI for Detection of Bacteria and Yeast
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Bloodstream Infection
Sepsis
Septic Shock
Lead sponsor: Microbio Co Ltd
Sponsor class: INDUSTRY
First posted: 2024-07-31
Enrollment: 1500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study seeks to enroll neonates (less than 1 month of age), pediatrics (between 1 month and 17 years of age) and adults (\>18 years of age) who are suspected to have a blood stream infection (BSI /Sepsis).

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Determine the sensitivity and specificity of InfectID-BSI versus blood culture.
timeFrame: Through study completion, an average of 1 year
measure: 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.
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University Hospital
state: Indiana
city: Baltimore
country: United States
facility: University of Maryland
state: Maryland
city: Albuquerque
country: United States
facility: TriCore Reference Laboratories
state: New Mexico
city: Nashville
country: United States
facility: Vanderbilt University Medical Centre
state: Tennessee
city: Houston
country: United States
facility: Texas Children's Hospital
state: Texas
city: Chermside
country: Australia
facility: The Prince Charles Hospital
state: Queensland
city: Woolloongabba
country: Australia
facility: The Princess Alexandra Hospital
state: Queensland
city: Bristol
country: United Kingdom
facility: Southwest Regional Laboratory, UK Health Security Agency, Bristol UK
Study officials:
References: