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

NCT06853301 | Not Yet Recruiting

• 2 other identifiers: 38RC24.0111_EMOC2024-A02517-40
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Bacteremia Sepsis

Keywords

Rapid identification; Positive blood culture; Electrochemical profiling; Machine learning; Artificial intelligence; Bacteremia; Database

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Identification performance

  End of the study (18 months)

Study Arms (1)

Patients

EXPERIMENTAL

Patients with blood culture sampling as standard of care. Two to four additional blood culture bottles sampled

Other: Blood culture sampling

Interventions

Blood culture sampling OTHER

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

Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Grenoble: lead
• CEA - Leti: collaborator

Study Sites (2)

Grenoble University Hospital

Grenoble, France

Location

Hôpital AVICENNE (AP-HP)

Paris, France

Location

Related Publications (3)

• 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 BACKGROUND

• 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 BACKGROUND

• 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

  BACKGROUND

MeSH Terms

Conditions

Bacteremia

Condition Hierarchy (Ancestors)

Bacterial Infections; Bacterial Infections and Mycoses; Infections; Sepsis; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Yvan CASPAR, PharmD, PhD

CONTACT

+33 476765479; YCaspar@chu-grenoble.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 11, 2025
• First Posted: February 28, 2025
• Study Start: April 1, 2025
• Primary Completion: April 1, 2025
• Study Completion (Estimated): August 1, 2026
• Last Updated: March 26, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)