Tuberculosis Diagnosis by Flow Cytometry

Reagent Evaluation Plan: Tuberculosis Diagnosis by Flow Cytometry (Project Orion)

Status

Withdrawn

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03639038

Enrollment

Registered

2018-08-20

Start date

2018-09-30

Completion date

2019-07-01

Last updated

2018-11-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tuberculosis

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: 1. Activated TB assay for differentiation of latent and active TB infection using blood samples and 2. Direct TB assay (DTA) for rapid detection and DST of Mycobacterium tuberculosis (Mtb) using sputum specimens.)

Interventions

None listed

Study design

Observational model

OTHER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

5 Years to 100 Years

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

Design outcomes

Primary

Measure	Time frame	Description
ATB assay for differentiation of latent and active TB infection using Blood samples	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
DTB assay for rapid detection and drug sensitivity testing of Mtb using sputum specimens	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

Countries

Zambia

Outcome results