Development and Accuracy Evaluation of Gram Staining Analysis AI

April 17, 2024 updated by: GramEye
The investigators use Gram-stained specimens provided from clinical settings to develop and evaluate the accuracy of Gram staining analysis AI

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

18000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Japan
    • Osaka
      • Suita, Osaka, Japan, 5650871
        • Recruiting
        • Osaka University Hospital
        • Contact:
          • Go Yamamoto

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

  • Patients in whom a Gram stain test was ordered

Exclusion Criteria:

  • No exclusion criteria

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Groups providing specimens for development of Gram Stain analysis AI
Other: Sample collection without intervention
No Intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Advanced level of blood culture Gram stain analysis AI accuracy
Time Frame: Day1
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
Time Frame: Day1

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GramEye

Investigators

  • Study Director: Satoshi Kutsuna, PhD, MD, Osaka University Medical Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 10, 2023

Primary Completion (Estimated)

March 31, 2027

Study Completion (Estimated)

March 31, 2027

Study Registration Dates

First Submitted

April 17, 2024

First Submitted That Met QC Criteria

April 17, 2024

First Posted (Actual)

April 22, 2024

Study Record Updates

Last Update Posted (Actual)

April 22, 2024

Last Update Submitted That Met QC Criteria

April 17, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • G22396

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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