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RecruitingNCT06519032Updated Jul 26, 2024

Development and Evaluation of Rapid Bacterial Species Identification for Acid-Fast Bacilli Smear Using Image Analysis AI

An observational study in Bacterial Infections, sponsored by GramEye. Recruiting at 1 site in Japan. Per ClinicalTrials.gov, last updated 2024-07-26.

Sponsored by GramEye · Observational

From the registry’s dates

  • Started Sep 2023; still recruiting 3 years later.
Study type
Observational
Model
Case-only
Time perspective
Retrospective
Enrollment
10,000
Sex
All
01

Study summary

The goal of this observational study is to develop AI that detects and classifies Acid-Fast Bacilli from microscope images using anonymized and fixed glass slides.

02

Conditions studied

  • Bacterial Infections

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03

In context

Bacterial Infections

658 studies on the registry are indexed under Bacterial Infections; 100 are open to participants now.

This study's planned enrollment of 10,000 is above the median of 200 across 229 observational studies indexed under Bacterial Infections.

Browse Bacterial Infections studies →

Lead sponsor

GramEye is the lead sponsor of 4 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Specimens for microbiological testing, such as acid-fast bacilli(AFB) smear test , ordered at the hospital.

Inclusion criteria

  • Patients in whom acid-fast bacilli(AFB) smear test was ordered

Exclusion criteria

Exclusion Criteria:

  • No exclusion criteria
05

Study design

Observational model
Case-only
Time perspective
Retrospective
Enrollment
10,000 participants (estimated)
Patient registry
No
Biospecimen retention
Samples without dna
06

What researchers measure

Primary outcomes

  1. Rate of concordance between AI-estimated results with actual culture results regarding the presence or absence of acid-fast bacteria

    Evaluate the difference between actual medical record reports(such as culture results) and AI-estimated results regarding the presence or absence of acid-fast bacteria

    Time frame: Day1

07

Study locations

1 of 1 sites recruiting
  • Osaka University Hospital
    Suita, Osaka 5650871, Japan
    • Go Yamamoto · Contact
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 26, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06519032
Lead sponsor
GramEye
Collaborators
Osaka University, Keio University, Fukujuji Hospital
Responsible party
Sponsor
First posted
Jul 25, 2024
Start date
Sep 20, 2023
Primary completion
Mar 2027 (estimated)
Completion
Mar 2027 (estimated)
Last update
Jul 26, 2024

Study contacts

Tatsuya Yamada, M.D.
Contact
tatsuya.yamada@grameye.com
7028060149
Satoshi Kutsuna, PhD,MD
study director · Osaka University Medical Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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