Tuberculosis Diagnosis by Flow Cytometry

Tuberculosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03639038
• Other study ID #: IRB-300001699
• Status: Withdrawn
• Start date: September 30, 2018
• Est. completion date: July 1, 2019

Study information

• Verified date: November 2018
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.)

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 1, 2019
• Est. primary completion date: April 1, 2019
• Gender: All
• Age group: 5 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Tuberculosis

Locations

Country	Name	City	State
Zambia	Center for Infectious Disease Research in Zambia (CIDRZ)	Lusaka

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

Zambia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ATB assay for differentiation of latent and active TB infection using Blood samples	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	The duration of this project is 9 months.
Primary	DTB assay for rapid detection and drug sensitivity testing of Mtb using sputum specimens	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	The duration of this project is 9 months.