NCT06554145

Brief Summary

The purpose of this research is to develop an AI that estimates bacterial species from Gram staining images of urine specimens, and to evaluate the accuracy and labor reduction effect of Gram staining Automation system equipped with this AI.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
15,000

participants targeted

Target at P75+ for all trials

Timeline
27mo left

Started Sep 2023

Longer than P75 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

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Study Timeline

Key milestones and dates

Study Progress54%
Sep 2023Aug 2028

Study Start

First participant enrolled

September 25, 2023

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

August 13, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 15, 2024

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2028

Last Updated

August 15, 2024

Status Verified

July 1, 2024

Enrollment Period

4.9 years

First QC Date

August 13, 2024

Last Update Submit

August 13, 2024

Conditions

Bacterial Infections

Outcome Measures

Primary Outcomes (1)

  • Rate of concordance between AI-estimated results with actual culture results regarding urine Gram stain specimens

    Evaluate the concordance rate between bacterial species estimation results and culture results obtained using the automatic Gram staining device with an AI program installed for analyzing urine Gram stain specimens.

    Day1

Eligibility Criteria

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

Specimens that have undergone urine culture and urine Gram staining for clinical purposes will be included.

You may qualify if:

  • Specimens for which urine culture and urine Gram staining tests were performed for clinical purposes

You may not qualify if:

  • Samples for which suspension of use has been requested

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Keio University Hospital

Shinjuku-Ku, Tokyo, 1608582, 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

Central Study Contacts

Tatsuya Yamada, 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

August 13, 2024

First Posted

August 15, 2024

Study Start

September 25, 2023

Primary Completion (Estimated)

August 1, 2028

Study Completion (Estimated)

August 1, 2028

Last Updated

August 15, 2024

Record last verified: 2024-07

Locations

JP(1)