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Recruiting

NCT Number: NCT06377592

Development and Accuracy Evaluation of Gram Staining Analysis AI

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

Recruiting

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Key information

Conditions

Bacterial Infections Bacterial Infections and Mycoses Infections

Sex eligibility

All sexes

Study type

Observational

Primary location

Osaka University Hospital

Suita, Osaka, 5650871, Japan

Location status: Recruiting

Location contact

Go Yamamoto

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients in whom a Gram stain test was ordered

Exclusion criteria

  • No exclusion criteria

Treatment and study plan

Sample collection without intervention

Other

No Intervention

Primary outcomes

  1. Advanced level of blood culture Gram stain analysis AI accuracy

    Time frame: 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.

  2. Ordinary level of blood culture Gram stain analysis AI accuracy

    Time frame: 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Tatsuya Yamada, M.D.

CONTACT

[email protected]

7028060149

Sponsors and collaborators

Lead sponsor

GramEye

Industry

Registry information

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Apr 22, 2024
Registry last updated
Apr 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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