Bacterial InfectionsNCT06377592
Development and Accuracy Evaluation of Gram Staining Analysis AI
An observational study of Bacterial Infections, run by GramEye at 1 site in Japan.
Trial summary
The investigators use Gram-stained specimens provided from clinical settings to develop and evaluate the accuracy of Gram staining analysis AI Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Bacterial Infections
- What is being tested?
- Sample collection without intervention
- How many people
- 18,000 participants
- Where
- 1 siteJapan
- Study dates
- 10 May 2023to 31 Mar 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Specimens for microbiological testing, such as Gram staining, ordered at the hospital.
Who may be able to join
- Patients in whom a Gram stain test was ordered
Who cannot join
- No exclusion criteria
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Japan1 site, 1 recruiting
- Recruiting
Osaka University Hospital
Suita, Osaka, 5650871
Go Yamamoto
About this study
The investigators use Gram-stained specimens provided from clinical settings to develop and evaluate the accuracy of Gram staining analysis AI
- Conditions
- Bacterial Infections
- Being tested
- Sample collection without intervention
- Medical subject headings
- Bacterial Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sample collection without interventionOther
No Intervention
| Study group | Role | What they receive |
|---|---|---|
| Groups providing specimens for development of Gram Stain analysis AI | Not described Receives: Other: Sample collection without intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Advanced level of blood culture Gram stain analysis AI accuracy
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.
Measured: Day1
Ordinary level of blood culture Gram stain analysis AI accuracy
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).
Measured: Day1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2024
- Study start10 May 2023
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bacterial InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 18,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- GramEye
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Satoshi Kutsuna, PhD, MD, Study director, Osaka University Medical Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06377592
- Sponsor's protocol ID
- G22396
- Status last verified
- Apr 2024
- First submitted
- 17 Apr 2024
- Last updated
- 22 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Accuracy Evaluation of Gram Staining Analysis AI
- ClinicalTrials.gov ID
- NCT06377592
- Acronym / sponsor ID
- G22396
- Conditions
- Bacterial Infections
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 18,000 participants (estimated)
- Lead sponsor
- GramEyeIndustry (pharma, biotech, devices)
- Study start
- 10 May 2023 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 22 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators use Gram-stained specimens provided from clinical settings to develop and evaluate the accuracy of Gram staining analysis AI
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Groups providing specimens for development of Gram Stain analysis AI | – | Other: Sample collection without intervention |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Specimens for microbiological testing, such as Gram staining, ordered at the hospital.
Key inclusion criteria (1 listed)
- Patients in whom a Gram stain test was ordered
Key exclusion criteria (1 listed)
- No exclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sample collection without interventionNo Intervention | Other | Groups providing specimens for development of Gram Stain analysis AI |
Primary outcome
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.
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Satoshi Kutsuna, PhD, MD study director
Osaka University Medical Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bacterial Infections, run by GramEye at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tatsuya Yamada, M.D. (7028060149, tatsuya.yamada@grameye.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Advanced level of blood culture Gram stain analysis AI accuracy (time frame: Day1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2024.