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Recruiting NCT06853301

Machine Learning Assisted Electrochemical Profiling to Provide Early Identification of Bloodstream Infections Pathogens

No phase Interventional Bacteremia Sepsis

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: Blood culture sampling.
Who it may be relevant to
Registry conditions: Bacteremia Sepsis. Basic parameters: from 18 years · 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
France
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

Towards a Smart Blood Culture Bottle: Machine Learning Assisted Electrochemical Profiling to Provide Early In-situ Identification of Bloodstream Infections Pathogens

Overview

In the context of a bacteremia, although significant progress has been made in speeding up pathogen identification once a blood culture bottle turns positive, few cost-effective solutions have been proposed to improve the earlier stages of the process-specifically, from blood collection to bottle positivity. The investigators propose that transport time could be leveraged to grow and identify bacteria, enabling faster access to actionable results through innovative technologies. This project aims to develop a bacterial identification database by analyzing the electrochemical profile of bacteria growing within the blood culture bottle, using machine learning.

Interventions

  • Other Blood culture sampling
    Patients with blood culture sampling as standard of care. Two to four additional blood culture bottles sampled that will be spiked with known bacterial species to determine their electrochemical profiles

Primary outcome measures

  • List of samples with an electrochemical profile [Time frame: From enrollment until the end of measurment of an electrochemical fingerprint in the blood cultures from the patient spiked with bacterial strains, assessed within up to one week after blood culture sampling]
Secondary outcome measures (1)
  • Identification performance [Time frame: End of the study (18 months)]

Eligibility criteria

Inclusion criteria

  • patient requiring a blood culture sample as standard of care procedure
  • body weight > 50 Kg
  • Patient for whom the collection of 2 to 4 additional blood culture bottles is feasible, depending on venous access
  • patient who has not objected to participation in the project

Exclusion criteria

  • Patient protected under the French Public Health Code (pregnant or breastfeeding women, patients under guardianship or curatorship, hospitalized under constraint, or deprived of liberty)
  • patients with ongoing antibiotic treatment at the time of sampling

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

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Diagnostic

Study locations

France · 2 centers
  • Grenoble University Hospital — Grenoble
  • Hôpital AVICENNE (AP-HP) — Paris

Publications

  • Lamy B, Sundqvist M, Idelevich EA; ESCMID Study Group for Bloodstream Infections, Endocarditis and Sepsis (ESGBIES). Bloodstream infections - Standard and progress in pathogen diagnostics. Clin Microbiol Infect. 2020 Feb;26(2):142-150. doi: 10.1016/j.cmi.2019.11.017. Epub 2019 Nov 22. PMID 31760113
  • Dubourg G, Lamy B, Ruimy R. Rapid phenotypic methods to improve the diagnosis of bacterial bloodstream infections: meeting the challenge to reduce the time to result. Clin Microbiol Infect. 2018 Sep;24(9):935-943. doi: 10.1016/j.cmi.2018.03.031. Epub 2018 Mar 29. PMID 29605563
  • T Babin, T Dedole, P Bouvet, PR Marcoux, M Gougis, P Mailley (2023) Electrochemical label-free pathogen identification for bloodstream infections diagnosis: towards a machine learning based smart blood culture bottle. Sensors and Actuators B. (open access) https://doi.org/10.1016/j.snb.2023.133748

Identifiers

NCT: NCT06853301 · 38RC24.0111_EMOC · 2024-A02517-40

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗