Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06143657
Other study ID # K22581
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date January 10, 2024
Est. completion date December 31, 2024

Study information

Verified date November 2023
Source GramEye
Contact Yamada Tatsuya, M.D.
Phone 7028060149
Email tatsuya.yamada@grameye.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The investigators have developed an analysis AI for Gram staining. In this study, the investigators will compare the testing accuracy of automated Gram staining equipment with AI with the testing accuracy of laboratory technicians. Based on the results, the investigators will examine the possibility of clinical application of the automated Gram staining device.


Description:

Gram staining,whitch provides crucial information for selecting antibiotics in the diagnosis and treatment of infectious diseases, is often manually performed in many laboratories, and the microscopic findings are subjectively interpreted and reported based on the experience of laboratory technicians. Automating the entire process from staining to microscopic examination, as achieved by the AI-equipped automatic Gram staining device, can reduce the labor required for Gram staining. This automation enables even less experienced technicians to quickly report Gram staining results. The aim of this study is to evaluate the accuracy of the Auto microscopic examination of Gram-stained samples using anonymized processed slides created from clinical specimens. This evaluation will be compared with the accuracy of microscopic examinations performed by hospital laboratory technicians. If the accuracy of the machine is demonstrated, it can be registered as a medical device and proceed to the implementation stage in actual clinical settings. The implementation of this device in clinical laboratories is expected to reduce workload, expedite processes, and contribute to the optimization of antibiotic use based on Gram staining results.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 1600
Est. completion date December 31, 2024
Est. primary completion date June 30, 2024
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: 1. Patients in whom a Gram stain test was ordered Exclusion Criteria: No exclusion criteria

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Automated Gram Staining Machine analysis
Measure urine and sputum specimens using this device.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
GramEye

Outcome

Type Measure Description Time frame Safety issue
Other Exploratory evaluation items The difference in accuracy rates of microscopic examination findings by technicians at each facility based on the technicians' years of experience. Day 1
Primary Primary Outcome The difference in accuracy rates between the Gram staining examination performed by laboratory technicians and the automated Gram staining device, including the approximate bacterial quantity based on Gram staining and morphology (categorized as -, 1+, 2+, 3+, 4+), presence of white blood cells, presence of phagocytic images, and, in the case of sputum, the Geckler classification. Day 1
Secondary Secondary Outcome Impact of specimen type and identified bacterial species on testing accuracy. Day 1
See also
  Status Clinical Trial Phase
Recruiting NCT05846399 - CAT BITE Antibiotic Prophylaxis for the Hand/Forearm (CATBITE) Phase 4
Recruiting NCT05904535 - Novel Diagnostic Methods to Identify External Ventricular Drain Associated Infections
Not yet recruiting NCT04075344 - Effect of a Infection Control Program on the Reduction of Bacterial Contamination on NG Tube Feeding in RCHEs N/A
Completed NCT05333133 - High Calorie Formula Intervention on Weight, Length Increment, Total Lymphocyte Counts, TNF-alpha and IGF-1 in Failure to Thrive Children N/A
Recruiting NCT05950984 - Medical Device (MD) Derived Pharmacokinetic (PK) Parameters for Vancomycin (MD-PK)
Recruiting NCT06283433 - A Dried Blood Spot Sampling Method for Vancomycin and Creatinine Monitoring for OPAT N/A
Recruiting NCT06178822 - Towards Novel BIOmarkers to Diagnose SEPsis on the Emergency Room
Completed NCT03688321 - Probiotic on Prevention of GBS Vaginal Infection During Pregnancy N/A
Completed NCT03244917 - Trial to Reduce Antimicrobial Use In Nursing Home Residents With Alzheimer's Disease and Other Dementias N/A
Recruiting NCT04450680 - Beta-lactam Therapeutic Drug Monitoring in Singapore
Completed NCT05686577 - How to Reduce Unnecessary Blood Cultures: Construction and Validation of a Predictive Score for Blood Culture Positivity in Intensive Care
Recruiting NCT06093269 - Pharmacokinetics Study of Cefazolin in Hemodialysis (CEFAZODIAL) Phase 4
Recruiting NCT05587283 - Safety, Tolerability, and Acceptability Study of Intravaginal Administration of LABTHERA-001 Capsules in Healthy Women Phase 1
Recruiting NCT03752424 - Topical Silver Nanoparticles for Microbial Activity Phase 1
Completed NCT04440631 - Gut Microbiome of Patients Undergoing Antibiotic Therapy for Orthopedic Device-related Infection
Active, not recruiting NCT05150015 - ElastoMeric Infusion Pumps for Hospital AntibioTICs N/A
Completed NCT03816956 - Adjunctive Therapy to Antibiotics in the Treatment of S. Aureus Ventilator-Associated Pneumonia With AR-301 Phase 3
Terminated NCT03555981 - Early Kangaroo Mother Care in Gambian Hospitalised Unstable Neonates N/A
Completed NCT03133312 - Chlorhexidine Gluconate Versus Povidone-Iodine as Vaginal Preparation Antiseptics Prior to Cesarean Delivery Phase 4
Recruiting NCT04800575 - Comparison of Sterile Gauze and Semi-permeable Film Dressing for Hemodialysis Central Venous Catheter N/A