Recruiting NCT06554145
Development and Evaluation of AI Program for Predicting Bacterial Species From Urine Gram Stain Specimens
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Bacterial Infections. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Japan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Primary outcome measures
- Rate of concordance between AI-estimated results with actual culture results regarding urine Gram stain specimens [Time frame: Day1]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
Japan · 1 center
- Keio University Hospital — Shinjuku-Ku
Identifiers
NCT: NCT06554145 · GE003