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Micro-hematology Analyzer for Viral/Bacterial Description

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ClinicalTrials.gov Identifier: NCT05090319
Recruitment Status : Recruiting
First Posted : October 22, 2021
Last Update Posted : November 3, 2021
Sponsor:
Collaborator:
Baylor College of Medicine
Information provided by (Responsible Party):
RizLab Health, Inc.

Brief Summary:
The purpose of the study is to evaluate the reliability and accuracy of a newly developed point-of-care analyzer, theCytoTracker, to measure complete blood count (CBC) parameters and discriminate between viral and bacterial infections.

Condition or disease Intervention/treatment
Infection Viral Infection, Bacterial Diagnostic Test: complete blood count

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.

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Use of a Micro-hematology Analyzer for Discriminating Between Viral and Bacterial Infections in Hospitalized Adults: An Observational Study
Actual Study Start Date : July 25, 2021
Estimated Primary Completion Date : July 24, 2022
Estimated Study Completion Date : July 24, 2022

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Viral Group
known viral infection
Diagnostic Test: complete blood count
Complete blood count will be performed on the patient. Accuracy of micro-hematology analyzer will be assessed.

Bacterial group
known bacterial infection
Diagnostic Test: complete blood count
Complete blood count will be performed on the patient. Accuracy of micro-hematology analyzer will be assessed.




Primary Outcome Measures :
  1. Accuracy [ Time Frame: 1 year ]
    Accuracy of Device in quantifying WBC, Neutrophils, and Lymphocytes; Accuracy of Viral/Bacterial Descrimination



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Emergency room patients
Criteria

Inclusion Criteria:

-COVID positive or suspected/confirmed bacterial infection (lower UTI, pneumonia, septecemia, etc). -Adults 18 years of age and older. -Meet SIRS criteria anytime during the ED presentation.

Exclusion Criteria:

  • Subjects who are unable to give informed consent will be excluded
  • Subjects with the following conditions will also be excluded: Known white blood cell, neutrophil, and lymphocyte disorders Active cancer patients; For solid tumors, subject will be excluded if he/she has received chemotherapy in the last 3 months.
  • Subjects who are pregnant

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05090319


Contacts
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Contact: Zubaid Rafique, MD 713-873-5297 rafique@bcm.edu

Locations
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United States, Texas
Ben Taub Hospital Recruiting
Houston, Texas, United States, 77030
Contact: Faisal Al Obaide    713-873-5297    Faisal.Alobaide@bcm.edu   
Principal Investigator: Zubaid Rafique, MD         
Sub-Investigator: Kelly Keene         
Sub-Investigator: Abeer Almasary         
Sub-Investigator: Samantha Sampilo         
Sub-Investigator: Nina James         
Sponsors and Collaborators
RizLab Health, Inc.
Baylor College of Medicine
Publications:

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Responsible Party: RizLab Health, Inc.
ClinicalTrials.gov Identifier: NCT05090319    
Other Study ID Numbers: H-49795
First Posted: October 22, 2021    Key Record Dates
Last Update Posted: November 3, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Infections
Communicable Diseases
Bacterial Infections
Virus Diseases
Disease Attributes
Pathologic Processes
Bacterial Infections and Mycoses