Micro-hematology Analyzer for Viral/Bacterial Description

Infection, Bacterial Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05090319
• Other study ID #: H-49795
• Status: Recruiting
• Start date: July 25, 2021
• Est. completion date: July 24, 2022

Study information

• Verified date: October 2021
• Source: RizLab Health, Inc.
• Contact: Zubaid Rafique, MD
• Phone: 713-873-5297
• Email: rafique[@]bcm.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: July 24, 2022
• Est. primary completion date: July 24, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Bacterial Infections
• Communicable Diseases
• Infection Viral
• Infection, Bacterial
• Infections
• Virus Diseases

Intervention

Diagnostic Test:
• complete blood count
Complete blood count will be performed on the patient. Accuracy of micro-hematology analyzer will be assessed.

Locations

Country	Name	City	State
United States	Ben Taub Hospital	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
RizLab Health, Inc.	Baylor College of Medicine

Country where clinical trial is conducted

United States, 

References & Publications (10)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Juul S, Pliskin JS, Fineberg HV. Variation and information in white blood cell differential counts. Med Decis Making. 1984;4(1):69-80. — View Citation

Korppi M, Kröger 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Accuracy	Accuracy of Device in quantifying WBC, Neutrophils, and Lymphocytes; Accuracy of Viral/Bacterial Descrimination	1 year