NCT06143657

Brief Summary

The investigators have developed an analysis AI for Gram staining. In this study, the investigators will compare the testing accuracy of automated Gram staining equipment with AI with the testing accuracy of laboratory technicians. Based on the results, the investigators will examine the possibility of clinical application of the automated Gram staining device.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
1,600

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2024

Shorter than P25 for all trials

Status
unknown

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

First Submitted

Initial submission to the registry

November 16, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 22, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

January 10, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

December 6, 2023

Status Verified

November 1, 2023

Enrollment Period

6 months

First QC Date

November 16, 2023

Last Update Submit

November 30, 2023

Conditions

Infection, Bacterial

Outcome Measures

Primary Outcomes (1)

  • Primary Outcome

    The difference in accuracy rates between the Gram staining examination performed by laboratory technicians and the automated Gram staining device, including the approximate bacterial quantity based on Gram staining and morphology (categorized as -, 1+, 2+, 3+, 4+), presence of white blood cells, presence of phagocytic images, and, in the case of sputum, the Geckler classification.

    Day 1

Secondary Outcomes (1)

  • Secondary Outcome

    Day 1

Other Outcomes (1)

  • Exploratory evaluation items

    Day 1

Interventions

Automated Gram Staining Machine analysisDIAGNOSTIC_TEST

Measure urine and sputum specimens using this device.

Eligibility Criteria

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

Specimens for microbiological testing, such as Gram staining, ordered at the hospital providing the specimens.

You may qualify if:

  • \. Patients in whom a Gram stain test was ordered

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Bacterial Infections

Condition Hierarchy (Ancestors)

Bacterial Infections and MycosesInfections

Study Officials

  • Yoshifumi UwaminoUwamino, Ph.D.

    Assistant professor, Keio University hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yamada Tatsuya, M.D.

CONTACT

7028060149tatsuya.yamada@grameye.com

Study Design

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

Study Record Dates

First Submitted

November 16, 2023

First Posted

November 22, 2023

Study Start

January 10, 2024

Primary Completion

June 30, 2024

Study Completion

December 31, 2024

Last Updated

December 6, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share