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Prospective Evaluation of Novel Diagnostics for Tuberculosis in KwaZulu-Natal, South Africa

NCT04583904 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 843

Last updated 2024-08-07

No results posted yet for this study

Summary

Tuberculosis (TB) infects nearly two billion people and has become the leading infectious cause of mortality worldwide, due in part to inadequate diagnostic and prognostic tests. Older diagnostic tools, such as acid-fast staining, and newer diagnostic tests, such as nucleic acid amplification, are either insensitive, expensive, or not suitable for use at the clinical point-of-care. Therefore, novel diagnostic tests are needed to diagnose active TB disease among adults, people living with HIV (PLHIV), and children in TB-endemic countries. In this project, the investigators will conduct clinical evaluation studies of emerging TB diagnostic tests among (1) hospitalized adults, (2) ambulatory adults in outpatient clinics, and (3) children \<12 years suspected of having active TB disease. the investigators will also maintain a biorepository of well-characterized clinical specimens that can be used for either retrospective validation of TB diagnostic tests, establishing a reference LAM test, or to share with partners developing novel TB diagnostics, including new LAM antibodies. The project will be coordinated at the University of Washington, and conducted in partnership with clinical research partners in South Africa, including Umkhuseli Innovation and Research Management (UIRM) and the National Health Laboratory Service (NHLS). The project team is well-equipped to serve as a central clinical research site to evaluate new and emerging point-of-care TB diagnostics, particularly novel urinary LAM assays, at the on-site TB Diagnostics Research Laboratory at Edendale Hospital in KwaZulu-Natal, South Africa.

Conditions

Sponsors & Collaborators

  • Umkhuseli Innovation and Research Management (UIRM)

    collaborator UNKNOWN

  • University of KwaZulu

    collaborator OTHER

  • PATH

    collaborator OTHER

  • KwaZulu Natal Department of Health

    collaborator UNKNOWN

  • Salus Ltd.

    collaborator INDUSTRY

  • University of Washington

    lead OTHER

Principal Investigators

  • Paul K. Drain, MD, MPH, FACP · University of Washington

  • Douglas Wilson, MD · University of KwaZulu

Eligibility

Min Age
12 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-18
Primary Completion
2022-08-31
Completion
2022-08-31

Countries

  • South Africa

Study Locations

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Diseases
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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04583904 on ClinicalTrials.gov