Tuberculosis Diagnosis by Flow Cytometry

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Tuberculosis

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 Type: Observational

Contacts and Locations

Study Locations

• Zambia
  • Lusaka, Zambia, 10102
    • Center for Infectious Disease Research in Zambia (CIDRZ)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 100 years (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Participants will be selected on a first come, first serve basis at TB clinics in MOH District clinics in Lusaka. The participants will include both confirmed TB patients as well as presumptive TB patients. All participants should not have started anti-TB treatment (ATT) prior to enrollment or be less than five days from treatment start.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

9

Cohorts and Interventions

Group / Cohort
Blood Assay Phase - 1; TB Positive / HIV Positive: 65 participants
Blood Assay Phase - 2; TB positive / HIV Negative: 65 participants
Blood Assay Phase - 3; TB positive and negative Paediatric: 30 participants
Blood Assay Phase - 4; TB Negative/HIV positive: 50 participants
Blood Assay Phase - 5; Healthy controls: 30 participants
Sputum Collection Phase - 1; TB Positive: Xpert Rif sensitive: 100 participants
Sputum Collection Phase - 2; TB Positive: Xpert Rif resistant: 20
Sputum Collection Phase - 3; TB Negative: Other chest: unknown number
Sputum Collection Phase - 4; TB Negative: Smear negative/Xpert negative: 20

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham
• Investigators: Principal Investigator: Monde Muyoyeta, MD, PhD, Center for Infectious Disease Research in Zambia

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): September 30, 2018
• Primary Completion (ANTICIPATED): April 1, 2019
• Study Completion (ANTICIPATED): July 1, 2019

Study Registration Dates

• First Submitted: August 14, 2018
• First Submitted That Met QC Criteria: August 14, 2018
• First Posted (ACTUAL): August 20, 2018

Study Record Updates

• Last Update Posted (ACTUAL): November 20, 2018
• Last Update Submitted That Met QC Criteria: November 16, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Actinomycetales Infections; Mycobacterium Infections; Tuberculosis
• Other Study ID Numbers: IRB-300001699

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No