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NCT06377592 Clinical Trial

Development and Accuracy Evaluation of Gram Staining Analysis AI

Bacterial Infections Clinical Trial

Official title:
Development and Accuracy Evaluation of Gram Staining Analysis AI

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06377592
Other study ID # G22396
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date May 10, 2023
Est. completion date March 31, 2027

Study information
Verified date April 2024
Source GramEye
Contact Tatsuya Yamada, M.D.
Phone 7028060149
Email tatsuya.yamada@grameye.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

Recruitment information / eligibility
Status Recruiting
Enrollment 18000
Est. completion date March 31, 2027
Est. primary completion date March 31, 2027
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - Patients in whom a Gram stain test was ordered Exclusion Criteria: - No exclusion criteria

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Sample collection without intervention
No Intervention

Locations
Country Name City State
Japan Osaka University Hospital Suita Osaka

Sponsors (1)
Lead Sponsor Collaborator
GramEye

Country where clinical trial is conducted

Japan, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
Primary 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
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