Bacterial InfectionsNCT06554145
Development and Evaluation of AI Program for Predicting Bacterial Species From Urine Gram Stain Specimens
An observational study of Bacterial Infections, run by GramEye at 1 site in Japan.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Bacterial Infections
- How many people
- 15,000 participants
- Where
- 1 siteJapan
- Study dates
- 25 Sep 2023to Aug 2028
- 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 that have undergone urine culture and urine Gram staining for clinical purposes will be included.
Who may be able to join
- Specimens for which urine culture and urine Gram staining tests were performed for clinical purposes
Who cannot join
- Samples for which suspension of use has been requested
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
Keio University Hospital
Shinjuku-Ku, Tokyo, 1608582
Yoshifumi Uwamino, MD PhD
About this study
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.
- Conditions
- Bacterial Infections
- Medical subject headings
- Bacterial Infections
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of concordance between AI-estimated results with actual culture results regarding urine Gram stain specimens
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.
Measured: Day1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2024
- Study start25 Sep 2023
- Primary completionAug 2028 (estimated)
- Study completionAug 2028 (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
- Prospective
- Enrolment
- 15,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- GramEye
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Keio University, Kameda Medical Center
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06554145
- Sponsor's protocol ID
- GE003
- Status last verified
- Jul 2024
- First submitted
- 13 Aug 2024
- Last updated
- 15 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Evaluation of AI Program for Predicting Bacterial Species From Urine Gram Stain Specimens
- ClinicalTrials.gov ID
- NCT06554145
- Acronym / sponsor ID
- GE003
- Conditions
- Bacterial Infections
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 15,000 participants (estimated)
- Lead sponsor
- GramEyeIndustry (pharma, biotech, devices)
- Collaborators
- Keio University, Kameda Medical Center
- Study start
- 25 Sep 2023 (actual)
- Primary completion
- Aug 2028 (estimated)
- Study completion
- Aug 2028 (estimated)
- First posted
- 15 Aug 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 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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Specimens that have undergone urine culture and urine Gram staining for clinical purposes will be included.
Key inclusion criteria (1 listed)
- Specimens for which urine culture and urine Gram staining tests were performed for clinical purposes
Key exclusion criteria (1 listed)
- Samples for which suspension of use has been requested
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Rate of concordance between AI-estimated results with actual culture results regarding urine Gram stain specimens
Time frame: 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.
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 15 Aug 2024.
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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.
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 15 Aug 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?
Rate of concordance between AI-estimated results with actual culture results regarding urine Gram stain specimens (time frame: Day1). 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 15 Aug 2024.