Recruiting

Observational Study

Sponsor:

RizLab Health, Inc.

Code:

NCT05090319

Conditions

Infection Viral

Infection, Bacterial

Eligibility Criteria

Sex: All

Age: 18 - 64

Healthy Volunteers: Not accepted

Interventions

complete blood count

Study Details

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

Study ID

NCT05090319

Start date

Jul 25, 2021

Status verified date

Oct, 2021

Completion date

Jul 24, 2022

Anticipated

Primary completion date

Jul 24, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 64

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

200 participants

Anticipated

Interventions and Outcome Measures

Arms

Viral Group

known viral infection

Bacterial group

known bacterial infection

Interventions

complete blood count

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

Primary outcome measure

  • Accuracy [ Time Frame: 1 year ]

Central Contacts and Locations

Central contacts

Zubaid Rafique, MD

713-873-5297rafique@bcm.edu

Locations

Ben Taub Hospital

Recruiting

Houston, Texas, United States, 77030

Contacts

Faisal Al Obaide

713-873-5297Faisal.Alobaide@bcm.edu

Principal Investigator:

Zubaid Rafique, MD

More Information

Sponsor

RizLab Health, Inc.

Last update posted

Nov 3, 2021

Last verified

Oct, 2021

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by RizLab Health, Inc. on 2021-11-03.