Tuberculosis Diagnosis by Flow Cytometry

The University of Alabama at Birmingham

Status: Withdrawn

Conditions: Tuberculosis

Study type: Observational

Funder types: Other

Identifiers

NCT03639038

IRB-300001699

Details and patient eligibility

About

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.

Full 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.)

Sex: All

Ages: 5 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

0 participants in 9 patient groups

Blood Assay Phase - 1

Description:

TB Positive / HIV Positive: 65 participants

Blood Assay Phase - 2

Description:

TB positive / HIV Negative: 65 participants

Blood Assay Phase - 3

Description:

TB positive and negative Paediatric: 30 participants

Blood Assay Phase - 4

Description:

TB Negative/HIV positive: 50 participants

Blood Assay Phase - 5

Description:

Healthy controls: 30 participants

Sputum Collection Phase - 1

Description:

TB Positive: Xpert Rif sensitive: 100 participants

Sputum Collection Phase - 2

Description:

TB Positive: Xpert Rif resistant: 20

Sputum Collection Phase - 3

Description:

TB Negative: Other chest: unknown number

Sputum Collection Phase - 4

Description:

TB Negative: Smear negative/Xpert negative: 20