Tuberculosis Diagnosis by Flow Cytometry

NCT03639038 | Withdrawn

• 1 other identifier: IRB-300001699
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Tuberculosis

Outcome Measures

Primary Outcomes (2)

• 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.

Study Arms (9)

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

Eligibility Criteria

• Age: 5 Years - 100 Years
• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Unable/unwilling to sign Informed consent

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

Center for Infectious Disease Research in Zambia (CIDRZ)

Lusaka, 10102, Zambia

Location

MeSH Terms

Conditions

Tuberculosis

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Officials

• Monde Muyoyeta, MD, PhD

  Center for Infectious Disease Research in Zambia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: co-investigator

Study Record Dates

• First Submitted: August 14, 2018
• First Posted: August 20, 2018
• Study Start: September 30, 2018
• Primary Completion: April 1, 2019
• Study Completion: July 1, 2019
• Last Updated: November 20, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share

Locations

ZA (1)