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

Recruiting

• Conditions: Bacterial Infections

• Registration Number: NCT06519032
• Lead Sponsor: GramEye

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-09-20
• Status Verified: 2024-07
• Study First Submitted: 2024-07-12
• Study First Submitted QC: 2024-07-19
• Last Update Submitted: 2024-07-24
• Study First Posted: 2024-07-25
• Last Update Posted: 2024-07-26
• Primary Completion: 2027-03
• Study Completion: 2027-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10000

Inclusion Criteria

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

Exclusion Criteria

• No exclusion criteria

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Rate of concordance between AI-estimated results with actual culture results regarding the presence or absence of acid-fast bacteria	Day1	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

Trial Locations

Locations (1)

Osaka University Hospital; 🇯🇵 Suita, Osaka, Japan