Ignite Creation Date:
2025-12-24 @ 3:35 PM
Ignite Modification Date:
2026-01-28 @ 4:23 PM
Study NCT ID:
NCT06377592
Status:
RECRUITING
Last Update Posted:
2024-04-22
First Post:
2024-04-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Development and Accuracy Evaluation of Gram Staining Analysis AI
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001424', 'term': 'Bacterial Infections'}], 'ancestors': [{'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D008722', 'term': 'Methods'}], 'ancestors': [{'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Blood Cluture, Urine, Sputum, and other specimen used for microbiologic testing'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 18000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-05-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2027-03-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-17', 'studyFirstSubmitDate': '2024-04-17', 'studyFirstSubmitQcDate': '2024-04-17', 'lastUpdatePostDateStruct': {'date': '2024-04-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-03-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Advanced level of blood culture Gram stain analysis AI accuracy', 'timeFrame': 'Day1', 'description': '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.'}, {'measure': 'Ordinary level of blood culture Gram stain analysis AI accuracy', 'timeFrame': 'Day1', 'description': 'Gram-stained microscopic images of blood culture-positive specimens are analyzed using AI, and bacteria are classified based on morphological classification.\n\nFor example, gram-positive cocci (GPC) are classified into gram-positive staphylococci (GCP clusters) and gram-positive streptococci (GPC chains).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Bacterial Infections']}, 'descriptionModule': {'briefSummary': 'The investigators use Gram-stained specimens provided from clinical settings to develop and evaluate the accuracy of Gram staining analysis AI'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Specimens for microbiological testing, such as Gram staining, ordered at the hospital.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients in whom a Gram stain test was ordered\n\nExclusion Criteria:\n\n* No exclusion criteria'}, 'identificationModule': {'nctId': 'NCT06377592', 'briefTitle': 'Development and Accuracy Evaluation of Gram Staining Analysis AI', 'organization': {'class': 'INDUSTRY', 'fullName': 'GramEye'}, 'officialTitle': 'Development and Accuracy Evaluation of Gram Staining Analysis AI', 'orgStudyIdInfo': {'id': 'G22396'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Groups providing specimens for development of Gram Stain analysis AI', 'interventionNames': ['Other: Sample collection without intervention']}], 'interventions': [{'name': 'Sample collection without intervention', 'type': 'OTHER', 'description': 'No Intervention', 'armGroupLabels': ['Groups providing specimens for development of Gram Stain analysis AI']}]}, 'contactsLocationsModule': {'locations': [{'zip': '5650871', 'city': 'Suita', 'state': 'Osaka', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Go Yamamoto', 'role': 'CONTACT'}], 'facility': 'Osaka University Hospital', 'geoPoint': {'lat': 34.76143, 'lon': 135.51567}}], 'centralContacts': [{'name': 'Tatsuya Yamada, M.D.', 'role': 'CONTACT', 'email': 'tatsuya.yamada@grameye.com', 'phone': '7028060149'}], 'overallOfficials': [{'name': 'Satoshi Kutsuna, PhD, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Osaka University Medical Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GramEye', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}