NCT06853301

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
17mo left

Started Jul 2026

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress5%
Jul 2026Jan 2028

First Submitted

Initial submission to the registry

February 11, 2025

Completed
17 days until next milestone

First Posted

Study publicly available on registry

February 28, 2025

Completed
1.4 years until next milestone

Study Start

First participant enrolled

July 13, 2026

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2028

Last Updated

July 22, 2026

Status Verified

July 1, 2026

Enrollment Period

1.5 years

First QC Date

February 11, 2025

Last Update Submit

July 20, 2026

Conditions

Bacteremia Sepsis

Keywords

Rapid identificationPositive blood cultureElectrochemical profilingMachine learningArtificial intelligenceBacteremiaDatabase

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 samplingOTHER

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

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Grenoble University Hospital

Grenoble, France

RECRUITING

Hôpital AVICENNE (AP-HP)

Paris, France

NOT YET RECRUITING

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: 31760113BACKGROUND

  • 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: 29605563BACKGROUND

  • 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 InfectionsBacterial Infections and MycosesInfectionsSepsisSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Yvan CASPAR, PharmD, PhD

CONTACT

+33 476765479YCaspar@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

July 13, 2026

Primary Completion (Estimated)

January 1, 2028

Study Completion (Estimated)

January 1, 2028

Last Updated

July 22, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Locations

FR(2)