Development and Accuracy Evaluation of Gram Staining Analysis AI

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06377592

Enrollment

18000

Registered

2024-04-22

Start date

2023-05-10

Completion date

2027-03-31

Last updated

2024-04-22

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

Interventions

OTHERSample collection without intervention

No Intervention

Study design

Observational model

CASE_ONLY

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

* Patients in whom a Gram stain test was ordered

Exclusion criteria

* No

Design outcomes

Primary

Measure	Time frame	Description
Advanced level of blood culture Gram stain analysis AI accuracy	Day1	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.
Ordinary level of blood culture Gram stain analysis AI accuracy	Day1	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).

Countries

Japan

Contacts

Primary ContactTatsuya Yamada, M.D.

tatsuya.yamada@grameye.com7028060149

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026