Infection ViralNCT05090319
Micro-hematology Analyzer for Viral/Bacterial Description
An observational study of Infection Viral and Infection, Bacterial, run by RizLab Health, Inc. at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Infection Viral, Infection, Bacterial
- What is being tested?
- complete blood count
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Jul 2021to 24 Jul 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Study population: Emergency room patients
Who may be able to join
- -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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Ben Taub Hospital
Houston, Texas, 77030
Faisal Al Obaide, 713-873-5297, Faisal.Alobaide@bcm.edu
Zubaid Rafique, MD
About this study
Official title: Use of a Micro-hematology Analyzer for Discriminating Between Viral and Bacterial Infections in Hospitalized Adults: An Observational Study
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.
Read the 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
- Infection Viral, Infection, Bacterial
- Being tested
- complete blood count
- Medical subject headings
- Virus Diseases, Bacterial Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
complete blood countDiagnostic test
Complete blood count will be performed on the patient. Accuracy of micro-hematology analyzer will be assessed.
| Study group | Role | What they receive |
|---|---|---|
| Viral Group | known viral infection Receives: Diagnostic Test: complete blood count | |
| Bacterial group | known bacterial infection Receives: Diagnostic Test: complete blood count |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy
Accuracy of Device in quantifying WBC, Neutrophils, and Lymphocytes; Accuracy of Viral/Bacterial Descrimination
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2021
- Study start25 Jul 2021
- Primary completion24 Jul 2022 (estimated)
- Study completion24 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Infection ViralStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RizLab Health, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Baylor College of Medicine
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05090319
- Sponsor's protocol ID
- H-49795
- Status last verified
- Oct 2021
- First submitted
- 12 Oct 2021
- Last updated
- 3 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 20548208Korppi 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.
PubMed 8248742Juul 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.
PubMed 6727589Kramer 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.
PubMed 8482999Jung 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.
PubMed 22226427Chaves 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.
PubMed 16191513Naess 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.
PubMed 27995553Furniturewalla 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.
PubMed 31057908Ahuja 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.
PubMed 31645995Power 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.
PubMed 22740357
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of a Micro-hematology Analyzer for Discriminating Between Viral and Bacterial Infections in Hospitalized Adults: An Observational Study
- ClinicalTrials.gov ID
- NCT05090319
- Acronym / sponsor ID
- H-49795
- Conditions
- Infection Viral, Infection, Bacterial
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- RizLab Health, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Baylor College of Medicine
- Study start
- 25 Jul 2021 (actual)
- Primary completion
- 24 Jul 2022 (estimated)
- Study completion
- 24 Jul 2022 (estimated)
- First posted
- 22 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Viral Group | – | Diagnostic Test: complete blood countknown viral infection |
| Bacterial group | – | Diagnostic Test: complete blood countknown bacterial infection |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Emergency room patients
Key inclusion criteria (1 listed)
- -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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| complete blood countComplete blood count will be performed on the patient. Accuracy of micro-hematology analyzer will be assessed. | Diagnostic test | Bacterial group, Viral Group |
Primary outcome
Accuracy
Time frame: 1 year
Accuracy of Device in quantifying WBC, Neutrophils, and Lymphocytes; Accuracy of Viral/Bacterial Descrimination
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2021.
- Background: PubMed 20548208Miller 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.
- Background: PubMed 8248742Korppi 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.
- Background: PubMed 6727589Juul 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.
- Background: PubMed 8482999Kramer 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.
- Background: PubMed 22226427Jung 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.
- Background: PubMed 16191513Chaves 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.
- Background: PubMed 27995553Naess 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.
- Background: PubMed 31057908Furniturewalla 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.
- Background: PubMed 31645995Ahuja 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.
- Background: PubMed 22740357Power 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infection Viral and Infection, Bacterial, run by RizLab Health, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zubaid Rafique, MD (713-873-5297, rafique@bcm.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05090319, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2021.