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Not yet recruiting NCT06531031

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

— Observational Bloodstream Infection Sepsis Septic Shock

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: InfectID-BSI (Bloodstream Infection) qPCR Assay.
Who it may be relevant to
Registry conditions: Bloodstream Infection, Sepsis, Septic Shock. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Australia, United Kingdom
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Clinical Performance Study of Microbio InfectID-BSI for Detection of Bacteria and Yeast

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.

Interventions

  • Diagnostic test InfectID-BSI (Bloodstream Infection) qPCR Assay
    InfectID-BSI technology targets nucleic acid sequences unique to the target analyte. The qPCR raw data collected from InfectID-BSI's 9 assay tubes is analysed by Microbio's InfectID-Client (InfectID-BSI-associated software) and the result is reported as an analyte-detection if the unique target analyte is present or no result if the unique target analyte is absent. InfectID-BSI is carried out with whole blood from a venous puncture (EDTA). DNA is extracted from a sample of the collected blood u

Primary outcome measures

  • Determine the sensitivity and specificity of InfectID-BSI versus blood culture. [Time frame: Through study completion, an average of 1 year]
  • 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. [Time frame: Through study completion, an average of 1 year]

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.
  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 5 centers
  • Indiana University Hospital — Indianapolis
  • University of Maryland — Baltimore
  • TriCore Reference Laboratories — Albuquerque
  • Vanderbilt University Medical Centre — Nashville
  • Texas Children's Hospital — Houston
Australia · 2 centers
  • The Prince Charles Hospital — Chermside
  • The Princess Alexandra Hospital — Woolloongabba
United Kingdom · 1 center
  • Southwest Regional Laboratory, UK Health Security Agency, Bristol UK — Bristol

Identifiers

NCT: NCT06531031 · MB-CLA-PRT-0022

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗