Machine Learning Assisted Electrochemical Profiling to Provide Early Identification of Bloodstream Infections Pathogens (E-MOC)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Bacteremia Sepsis
• Intervention / Treatment: Other: Blood culture sampling

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yvan CASPAR, PharmD, PhD; Phone Number: +33 476765479; Email: YCaspar@chu-grenoble.fr

Study Locations

• France
  • Grenoble, France
    • Grenoble University Hospital
    • Contact: Yvan CASPAR; Phone Number: 33 (0)4 76 76 63 12; Email: YCaspar@chu-grenoble.fr
  • Paris, France
    • Hôpital Avicenne (AP-HP)
    • Contact: Nicolas VIGNIER; Phone Number: 33 (0)1 48 95 54 21; Email: nicolas.vignier@aphp.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Patients; Patients with blood culture sampling as standard of care. Two to four additional blood culture bottles sampled	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
List of samples with an electrochemical profile	List of samples (bacterial strain and corresponding pseudonymized blood culture) for which an electrochemical profile of the growing bacteria within the blood culture bottle was successfully obtained	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

Outcome Measure	Measure Description	Time Frame
Identification performance	Identification performance of electrochemical profiling of the growing bacteria followed by machine learning analysis	End of the study (18 months)

Collaborators and Investigators

• Sponsor: University Hospital, Grenoble
• Collaborators: CEA - Leti

Publications and helpful links

General 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.
• 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.
• 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

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2025
• Primary Completion (Estimated): April 1, 2025
• Study Completion (Estimated): August 1, 2026

Study Registration Dates

• First Submitted: February 11, 2025
• First Submitted That Met QC Criteria: February 24, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Estimated): March 26, 2025
• Last Update Submitted That Met QC Criteria: March 25, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: Bacteremia; Artificial intelligence; Database; Machine learning; Rapid identification; Positive blood culture; Electrochemical profiling
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Bacterial Infections; Bacterial Infections and Mycoses; Bacteremia; Sepsis
• Other Study ID Numbers: 38RC24.0111_EMOC; 2024-A02517-40 (Other Identifier: ID RCB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No