NCT06519032

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.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
10,000

participants targeted

Target at P75+ for all trials

Timeline
10mo left

Started Sep 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

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 Progress76%
Sep 2023Mar 2027

Study Start

First participant enrolled

September 20, 2023

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

July 12, 2024

Completed
13 days until next milestone

First Posted

Study publicly available on registry

July 25, 2024

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2027

Last Updated

July 26, 2024

Status Verified

July 1, 2024

Enrollment Period

3.4 years

First QC Date

July 12, 2024

Last Update Submit

July 24, 2024

Conditions

Bacterial Infections

Outcome Measures

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

    Day1

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Osaka University Hospital

Suita, Osaka, 5650871, Japan

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Sputum and other specimen used for microbiologic testing

MeSH Terms

Conditions

Bacterial Infections

Condition Hierarchy (Ancestors)

Bacterial Infections and MycosesInfections

Study Officials

  • Satoshi Kutsuna, PhD,MD

    Osaka University Medical Hospital

    STUDY DIRECTOR

Central Study Contacts

Tatsuya Yamada, M.D.

CONTACT

7028060149tatsuya.yamada@grameye.com

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 12, 2024

First Posted

July 25, 2024

Study Start

September 20, 2023

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

March 1, 2027

Last Updated

July 26, 2024

Record last verified: 2024-07

Locations

JP(1)