NCT06377592

Brief Summary

The investigators use Gram-stained specimens provided from clinical settings to develop and evaluate the accuracy of Gram staining analysis AI

Trial Health

77
On Track

Trial Health Score

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

Enrollment
18,000

participants targeted

Target at P75+ for all trials

Timeline
11mo left

Started May 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress77%
May 2023Mar 2027

Study Start

First participant enrolled

May 10, 2023

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

April 17, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 22, 2024

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2027

Last Updated

April 22, 2024

Status Verified

April 1, 2024

Enrollment Period

3.9 years

First QC Date

April 17, 2024

Last Update Submit

April 17, 2024

Conditions

Bacterial Infections

Outcome Measures

Primary Outcomes (2)

  • Advanced level of blood culture Gram stain analysis AI accuracy

    Analyzing Gram-stained microscopic images of blood culture-positive specimens using AI and evaluating the accuracy of bacterial species estimation For example, classify GPC clusters as S. aureus or CNS.

    Day1

  • Ordinary level of blood culture Gram stain analysis AI accuracy

    Gram-stained microscopic images of blood culture-positive specimens are analyzed using AI, and bacteria are classified based on morphological classification. For example, gram-positive cocci (GPC) are classified into gram-positive staphylococci (GCP clusters) and gram-positive streptococci (GPC chains).

    Day1

Study Arms (1)

Groups providing specimens for development of Gram Stain analysis AI

Other: Sample collection without intervention

Interventions

Sample collection without interventionOTHER

No Intervention

Groups providing specimens for development of Gram Stain analysis AI

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 Gram staining, ordered at the hospital.

You may qualify if:

  • Patients in whom a Gram stain 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

Blood Cluture, Urine, Sputum, and other specimen used for microbiologic testing

MeSH Terms

Conditions

Bacterial Infections

Interventions

Specimen HandlingMethods

Condition Hierarchy (Ancestors)

Bacterial Infections and MycosesInfections

Intervention Hierarchy (Ancestors)

Clinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative Techniques

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

April 17, 2024

First Posted

April 22, 2024

Study Start

May 10, 2023

Primary Completion (Estimated)

March 31, 2027

Study Completion (Estimated)

March 31, 2027

Last Updated

April 22, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations

JP(1)