Clinical trial Recruiting at 1 site Observational

Evaluating AI for Gram Staining Analysis

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

Run by GramEye · NCT06377592 · Data updated 2026-11-12

This study is testing a new artificial intelligence tool to see if it can help doctors more accurately identify bacterial infections from lab samples.

Quick facts

Study typeObservational
SexAll
Enrollment18000 (estimated)
SponsorGramEye
Industry-sponsored
Locations1 site (Suita, Osaka)
StatusRecruiting
StartedMay 10, 2023
Main results expectedMarch 31, 2027
Study endsMarch 31, 2027
Registry record updatedApril 22, 2024
Trial IDNCT06377592 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates for this study are patients for whom a Gram stain test has been ordered.

Probably not a fit

Patients who have not undergone a Gram stain test will not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study focuses on developing and assessing the accuracy of an artificial intelligence system designed to analyze Gram-stained specimens collected from clinical settings. By utilizing samples from patients who have undergone Gram stain testing, the researchers aim to enhance the diagnostic capabilities of bacterial infection identification. The approach is observational, meaning it will analyze existing data without any direct intervention on the patients. The goal is to improve the efficiency and accuracy of bacterial infection diagnostics through advanced technology.

Why it matters

Potential benefit: If successful, this AI system could significantly improve the speed and accuracy of diagnosing bacterial infections, leading to better patient outcomes.

How similar studies have gone: While the use of AI in medical diagnostics is a growing field, this specific application of AI for Gram staining analysis is relatively novel and has not been extensively tested in prior studies.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* Patients in whom a Gram stain test was ordered

Exclusion Criteria:

* No exclusion criteria

Where it's running

  • Osaka University Hospital
    Suita, Osaka, Japan
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.