Micro-hematology Analyzer for Viral/Bacterial Description

Status Recruiting

Clinical Trial Summary

Clinical Trial Description

The purpose of the study is to evaluate the reliability and accuracy of a newly developed point-of-care analyzer, the CytoTracker, to measure complete blood count (CBC) parameters. The CytoTracker results will be compared to those from a standard benchtop analyzer (Horiba Point of Care Hematology Analyzer, ABX Micros ES 60). If successful, the data from this study would be used to support a pre-submission meeting to the FDA for the CytoTracker. In addition to validating the CytoTracker, the project will study the use of CBC parameters to distinguish between observed bacterial or viral infections in adults. Hospitalized adult subjects with suspected or confirmed viral or bacterial infections will be enrolled in the study. After enrollment a venous blood sample (baseline sample) will be collected and the CytoTracker will be used to measure CBC parameters (cell counts and population distribution). Clinical data will be abstracted from the medical record and used with the CBC parameters to develop an algorithm to distinguish between bacterial and viral infections. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05090319
Study type	Observational
Source	RizLab Health, Inc.
Contact	Zubaid Rafique, MD
Phone	713-873-5297
Email	rafique@bcm.edu
Status	Recruiting
Phase
Start date	July 25, 2021
Completion date	July 24, 2022

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