Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
OBSERVATIONAL
2018-09-30
2019-07-01
Brief Summary
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Detailed Description
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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.)
Conditions
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Study Design
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OTHER
PROSPECTIVE
Study Groups
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Blood Assay Phase - 1
TB Positive / HIV Positive: 65 participants
No interventions assigned to this group
Blood Assay Phase - 2
TB positive / HIV Negative: 65 participants
No interventions assigned to this group
Blood Assay Phase - 3
TB positive and negative Paediatric: 30 participants
No interventions assigned to this group
Blood Assay Phase - 4
TB Negative/HIV positive: 50 participants
No interventions assigned to this group
Blood Assay Phase - 5
Healthy controls: 30 participants
No interventions assigned to this group
Sputum Collection Phase - 1
TB Positive: Xpert Rif sensitive: 100 participants
No interventions assigned to this group
Sputum Collection Phase - 2
TB Positive: Xpert Rif resistant: 20
No interventions assigned to this group
Sputum Collection Phase - 3
TB Negative: Other chest: unknown number
No interventions assigned to this group
Sputum Collection Phase - 4
TB Negative: Smear negative/Xpert negative: 20
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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
5 Years
100 Years
ALL
No
Sponsors
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University of Alabama at Birmingham
OTHER
Responsible Party
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Stewart Reid
co-investigator
Principal Investigators
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Monde Muyoyeta, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Center for Infectious Disease Research in Zambia
Locations
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Center for Infectious Disease Research in Zambia (CIDRZ)
Lusaka, , Zambia
Countries
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Other Identifiers
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IRB-300001699
Identifier Type: -
Identifier Source: org_study_id
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