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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT03639038
Other study ID # IRB-300001699
Secondary ID
Status Withdrawn
Phase
First received
Last updated
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
Health authority
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Status Withdrawn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
Accepts healthy volunteers
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

Study Design


Related Conditions & MeSH terms


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.
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