Tuberculosis Diagnosis by Flow Cytometry

Withdrawn

• Conditions: Tuberculosis

• Registration Number: NCT03639038
• Lead Sponsor: University of Alabama at Birmingham

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.)

Study Timeline

• Study First Submitted: 2018-08-14
• Study First Submitted QC: 2018-08-14
• Study First Posted: 2018-08-20
• Study Start: 2018-09-30
• Status Verified: 2018-11
• Last Update Submitted: 2018-11-16
• Last Update Posted: 2018-11-20
• Primary Completion: 2019-04-01
• Study Completion: 2019-07-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

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Exclusion Criteria

• Unable/unwilling to sign Informed consent

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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
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

Trial Locations

Locations (1)

Center for Infectious Disease Research in Zambia (CIDRZ); 🇿🇲 Lusaka, Zambia