Micro-hematology Analyzer for Viral/Bacterial Description

NCT ID: NCT05090319

Last Updated: 2021-11-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-07-25

Study Completion Date

2022-07-24

Brief Summary

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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.

Detailed Description

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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

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Infection Viral Infection, Bacterial

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Viral Group

known viral infection

complete blood count

Intervention Type DIAGNOSTIC_TEST

Complete blood count will be performed on the patient. Accuracy of micro-hematology analyzer will be assessed.

Bacterial group

known bacterial infection

complete blood count

Intervention Type DIAGNOSTIC_TEST

Complete blood count will be performed on the patient. Accuracy of micro-hematology analyzer will be assessed.

Interventions

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complete blood count

Complete blood count will be performed on the patient. Accuracy of micro-hematology analyzer will be assessed.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Baylor College of Medicine

OTHER

Sponsor Role collaborator

RizLab Health, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Ben Taub Hospital

Houston, Texas, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Zubaid Rafique, MD

Role: CONTACT

Phone: 713-873-5297

Email: [email protected]

Facility Contacts

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Faisal Al Obaide

Role: primary

References

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Miller J, Starks B. Deciphering clues in the CBC count. Nursing. 2010 Jul;40(7):52-5. doi: 10.1097/01.NURSE.0000383454.33035.4b. No abstract available.

Reference Type BACKGROUND
PMID: 20548208 (View on PubMed)

Korppi M, Kroger L, Laitinen M. White blood cell and differential counts in acute respiratory viral and bacterial infections in children. Scand J Infect Dis. 1993;25(4):435-40. doi: 10.3109/00365549309008524.

Reference Type BACKGROUND
PMID: 8248742 (View on PubMed)

Juul S, Pliskin JS, Fineberg HV. Variation and information in white blood cell differential counts. Med Decis Making. 1984;4(1):69-80. doi: 10.1177/0272989X8400400110.

Reference Type BACKGROUND
PMID: 6727589 (View on PubMed)

Kramer MS, Tange SM, Mills EL, Ciampi A, Bernstein ML, Drummond KN. Role of the complete blood count in detecting occult focal bacterial infection in the young febrile child. J Clin Epidemiol. 1993 Apr;46(4):349-57. doi: 10.1016/0895-4356(93)90149-u.

Reference Type BACKGROUND
PMID: 8482999 (View on PubMed)

Jung YJ, Kim JH, Park YJ, Kahng J, Lee H, Lee KY, Kim MY, Han K, Lee W. Evaluation of cell population data on the UniCel DxH 800 Coulter Cellular Analysis system as a screening for viral infection in children. Int J Lab Hematol. 2012 Jun;34(3):283-9. doi: 10.1111/j.1751-553X.2011.01392.x. Epub 2012 Jan 9.

Reference Type BACKGROUND
PMID: 22226427 (View on PubMed)

Chaves F, Tierno B, Xu D. Quantitative determination of neutrophil VCS parameters by the Coulter automated hematology analyzer: new and reliable indicators for acute bacterial infection. Am J Clin Pathol. 2005 Sep;124(3):440-4. doi: 10.1309/LLF7-5W0F-WQQ8-TCC5.

Reference Type BACKGROUND
PMID: 16191513 (View on PubMed)

Naess A, Nilssen SS, Mo R, Eide GE, Sjursen H. Role of neutrophil to lymphocyte and monocyte to lymphocyte ratios in the diagnosis of bacterial infection in patients with fever. Infection. 2017 Jun;45(3):299-307. doi: 10.1007/s15010-016-0972-1. Epub 2016 Dec 19.

Reference Type BACKGROUND
PMID: 27995553 (View on PubMed)

Furniturewalla A, Chan M, Sui J, Ahuja K, Javanmard M. Fully integrated wearable impedance cytometry platform on flexible circuit board with online smartphone readout. Microsyst Nanoeng. 2018 Jul 30;4:20. doi: 10.1038/s41378-018-0019-0. eCollection 2018.

Reference Type BACKGROUND
PMID: 31057908 (View on PubMed)

Ahuja K, Rather GM, Lin Z, Sui J, Xie P, Le T, Bertino JR, Javanmard M. Toward point-of-care assessment of patient response: a portable tool for rapidly assessing cancer drug efficacy using multifrequency impedance cytometry and supervised machine learning. Microsyst Nanoeng. 2019 Jul 15;5:34. doi: 10.1038/s41378-019-0073-2. eCollection 2019.

Reference Type BACKGROUND
PMID: 31645995 (View on PubMed)

Power M, Fell G, Wright M. Principles for high-quality, high-value testing. Evid Based Med. 2013 Feb;18(1):5-10. doi: 10.1136/eb-2012-100645. Epub 2012 Jun 27.

Reference Type BACKGROUND
PMID: 22740357 (View on PubMed)

Other Identifiers

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H-49795

Identifier Type: -

Identifier Source: org_study_id