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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06554145

Enrollment

15000

Registered

2024-08-15

Start date

2023-09-25

Completion date

2028-08-31

Last updated

2024-08-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bacterial Infections

Brief summary

The purpose of this research is to develop an AI that estimates bacterial species from Gram staining images of urine specimens, and to evaluate the accuracy and labor reduction effect of Gram staining Automation system equipped with this AI.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Rate of concordance between AI-estimated results with actual culture results regarding urine Gram stain specimens	Day1	Evaluate the concordance rate between bacterial species estimation results and culture results obtained using the automatic Gram staining device with an AI program installed for analyzing urine Gram stain specimens.

Countries

Japan

Contacts

Primary ContactTatsuya Yamada, M.D.

tatsuya.yamada@grameye.com7028060149

Outcome results