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

NCT ID: NCT04583904

Last Updated: 2024-08-07

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 843 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-09-18
• Study Completion Date: 2022-08-31

Brief 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

Tuberculosis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Adults - inpatient

No interventions assigned to this group

Adults- ambulatory

No interventions assigned to this group

Children

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

Phase I

1. Eligibility for hospitalized and ambulatory adults:

• ≥16 years old
• Positive Xpert MTB/RIF Ultra test (TB-positive cohort) or no suspicion of clinical TB (TB-negative cohort)
• Have a documented HIV test result or agrees to test for HIV
• Have NOT received IPT within prior 3 months
• Have NOT received anti-TB treatment for more than 24 hours
• Willing/able to provide written informed consent

Phase II:

1. Eligibility for hospitalized adults:

• ≥16 years old
• Admitted to inpatient medical ward <72 hours
• Have a documented positive HIV test
• Have NOT received IPT within prior 3 months
• Have NOT received anti-TB treatment for more than 24 hours
• Willing/able to provide written informed consent

Study population description:

2. Eligibility for Xpert+ adults (hospitalized and attending outpatient clinics)

• ≥16 years old
• Have a documented HIV test result or agrees to test for HIV
• Positive Xpert MDR/RIF Ultra test documented.
• Have NOT received anti-TB treatment for more than 24 hours
• Willing/able to provide written informed consent

3) Eligibility for children

• children <12 years of age
• suspected of having active TB disease by clinical team
• Have a documented HIV test result or agrees to test for HIV
• Have not had IPT within 3 months
• Have not received anti-TB treatment for more than 24 hours within the prior 5 days
• Parent or guardian is willing/able to provide written informed consent

• Minimum Eligible Age: 12 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Umkhuseli Innovation and Research Management (UIRM)

UNKNOWN

Sponsor Role: collaborator

University of KwaZulu

OTHER

Sponsor Role: collaborator

PATH

OTHER

Sponsor Role: collaborator

KwaZulu Natal Department of Health

UNKNOWN

Sponsor Role: collaborator

Salus Ltd.

INDUSTRY

Sponsor Role: collaborator

University of Washington

OTHER

Sponsor Role: lead

Responsible Party

Paul Drain

Associate Professor of Global Health, Medicine and Epidemiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Paul K. Drain, MD, MPH, FACP

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Douglas Wilson, MD

Role: PRINCIPAL_INVESTIGATOR

University of KwaZulu

Locations

Edendale Hospital

Pietermaritzburg, , South Africa

Countries

South Africa

Other Identifiers

OPP1213504

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

STUDY00009092

Identifier Type: -

Identifier Source: org_study_id