Micro-hematology Analyzer for Viral/Bacterial Description

NCT05090319 | Unknown

• 1 other identifier: H-49795
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Infection Viral; Infection, Bacterial

Outcome Measures

Primary Outcomes (1)

• Accuracy

  Accuracy of Device in quantifying WBC, Neutrophils, and Lymphocytes; Accuracy of Viral/Bacterial Descrimination

  1 year

Study Arms (2)

Viral Group

known viral infection

Diagnostic Test: complete blood count

Bacterial group

known bacterial infection

Diagnostic Test: complete blood count

Interventions

complete blood count DIAGNOSTIC_TEST

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

Bacterial group; Viral Group

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Emergency room patients

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• RizLab Health, Inc.: lead
• Baylor College of Medicine: collaborator

Study Sites (1)

Ben Taub Hospital

Houston, Texas, 77030, United States

RECRUITING

Related Publications (10)

• 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.

  PMID: 20548208 BACKGROUND

• 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.

  PMID: 8248742 BACKGROUND

• 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.

  PMID: 6727589 BACKGROUND

• 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.

  PMID: 8482999 BACKGROUND

• 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.

  PMID: 22226427 BACKGROUND

• 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.

  PMID: 16191513 BACKGROUND

• 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.

  PMID: 27995553 BACKGROUND

• 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.

  PMID: 31057908 BACKGROUND

• 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.

  PMID: 31645995 BACKGROUND

• 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.

  PMID: 22740357 BACKGROUND

MeSH Terms

Conditions

Virus Diseases; Bacterial Infections

Interventions

Blood Cell Count

Condition Hierarchy (Ancestors)

Infections; Bacterial Infections and Mycoses

Intervention Hierarchy (Ancestors)

Cell Count; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Hematologic Tests; Investigative Techniques; Cell Physiological Phenomena; Blood Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Central Study Contacts

Zubaid Rafique, MD

CONTACT

713-873-5297; rafique@bcm.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2021
• First Posted: October 22, 2021
• Study Start: July 25, 2021
• Primary Completion: July 24, 2022
• Study Completion: July 24, 2022
• Last Updated: November 3, 2021

Record last verified: 2021-10

Locations

US (1)