Trials / Unknown

UnknownNCT05090319

Micro-hematology Analyzer for Viral/Bacterial Description

Use of a Micro-hematology Analyzer for Discriminating Between Viral and Bacterial Infections in Hospitalized Adults: An Observational Study

Status: Unknown
Phase: —
Study type: Observational
Enrollment: 200 (estimated)

Sponsor: RizLab Health, Inc. · Industry
Sex: All
Age: 18 Years – 64 Years
Healthy volunteers: Not accepted

Summary

Detailed 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.

Conditions

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	complete blood count	Complete blood count will be performed on the patient. Accuracy of micro-hematology analyzer will be assessed.

Timeline

Start date: 2021-07-25
Primary completion: 2022-07-24
Completion: 2022-07-24
First posted: 2021-10-22
Last updated: 2021-11-03

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT05090319. Inclusion in this directory is not an endorsement.