Reagent Evaluation Plan: Tuberculosis Diagnosis by Flow Cytometry (Project Orion)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Locations
- 1
- Primary Endpoint
- DTB assay for rapid detection and drug sensitivity testing of Mtb using sputum specimens
Study Overview
Brief Summary
Tuberculosis and HIV continue to be major public health problems in resource constrained settings like Zambia. Zambia is among the top 30 highest burden countries globally. The major drivers of TB in the Africa region is the HIV epidemic. Inadequate TB diagnostic tools with failure to make a timely diagnosis and start appropriate treatment are the major impediments to TB control in Zambia and globally.
Detailed Description
Project Orion is focused on utilizing Flow Cytometry Technology to screen and diagnose tuberculosis. There are two assays being tested under this Project:
- Activated TB assay for differentiation of latent and active TB infection using blood samples and
- Direct TB assay (DTA) for rapid detection and DST of Mycobacterium tuberculosis (Mtb) using sputum specimens.)
Study Design
- Study Type
- Observational
- Observational Model
- Other
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 5 Years to 100 Years (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Presumptive TB patients (patients recommended for tuberculosis diagnostic testing and not on ATT)
- •Patients with multi-drug resistant TB (MDR-TB)
- •Paediatric patients (< 15 years old)
- •Patients suspected of extra-pulmonary tuberculosis
- •Patients with TB/HIV co-infection
Exclusion Criteria
- •Unable/unwilling to sign Informed consent
Outcomes
Primary Outcomes
DTB assay for rapid detection and drug sensitivity testing of Mtb using sputum specimens
Time Frame: The duration of this project is 9 months.
To evaluate the clinical utility of the test reagent(s) compared to diagnostic gold Standard: Culture and Xpert MTB/Rif along with clinical (empiric) diagnosis
ATB assay for differentiation of latent and active TB infection using Blood samples
Time Frame: The duration of this project is 9 months.
To evaluate the clinical utility of the test reagent(s) compared to diagnostic gold Standard: Culture and Xpert MTB/Rif along with clinical (empiric) diagnosis
Secondary Outcomes
No secondary outcomes reported
Investigators
Stewart Reid
co-investigator
University of Alabama at Birmingham