Clinical trial NCT06853301: Machine Learning Assisted Electrochemical Profiling to Provide Early Identification of Bloodstream Infections Pathogens
Official title: Towards a Smart Blood Culture Bottle: Machine Learning Assisted Electrochemical Profiling to Provide Early In-situ Identification of Bloodstream Infections Pathogens
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Bacteremia Sepsis
Keywords: Rapid identification
Positive blood culture
Electrochemical profiling
Machine learning
Artificial intelligence
Bacteremia
Database
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
Collaborators: name: CEA - Leti
First posted: 2025-02-28
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


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

Primary outcomes:
measure: List of samples with an electrochemical profile
timeFrame: 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:
measure: Identification performance
timeFrame: End of the study (18 months)
Other outcomes:
Locations:
city: Grenoble
country: France
facility: Grenoble University Hospital
city: Paris
country: France
facility: Hôpital AVICENNE (AP-HP)
Study officials:
References:
citation: 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.
citation: 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.
citation: 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