Clinical trial Recruiting at 1 site Observational

AI program predicts bacterial species from urine Gram stain specimens

Official title: Development and Evaluation of AI Program for Predicting Bacterial Species From Urine Gram Stain Specimens

Run by GramEye · NCT06554145 · Data updated 2026-11-12

This study is testing a new AI program that helps doctors quickly and accurately identify bacteria in urine samples to make diagnosing infections easier.

Quick facts

Study typeObservational
SexAll
Enrollment15000 (estimated)
SponsorGramEye
Industry-sponsored
Locations1 site (Shinjuku-Ku, Tokyo)
StatusRecruiting
StartedSeptember 25, 2023
Main results expectedAugust 2028
Study endsAugust 2028
Registry record updatedAugust 15, 2024
Trial IDNCT06554145 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates for this study are patients whose urine specimens are being tested for bacterial infections through Gram staining and culture.

Probably not a fit

Patients whose urine samples are not suitable for Gram staining or have requested suspension of use may 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 research aims to develop an artificial intelligence program that can accurately identify bacterial species from images of Gram-stained urine specimens. The study will evaluate the effectiveness of this AI in improving the accuracy of bacterial identification and reducing the labor involved in the Gram staining process. By automating this aspect of microbiological analysis, the study seeks to enhance diagnostic efficiency in clinical settings.

Why it matters

Potential benefit: If successful, this AI program could significantly improve the speed and accuracy of diagnosing bacterial infections in patients.

How similar studies have gone: While the use of AI in medical diagnostics is a growing field, this specific approach to automating Gram stain 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:

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

Exclusion Criteria:

* Samples for which suspension of use has been requested

Where it's running

  • Keio University Hospital
    Shinjuku-Ku, Tokyo, Japan
    Recruiting

Study contacts

Similar studies

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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.