Clinical trial NCT04583904: Prospective Evaluation of Novel Diagnostics for Tuberculosis in KwaZulu-Natal, South Africa
Official title: Prospective Evaluation of Novel Diagnostics for Tuberculosis in KwaZulu-Natal, South Africa
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Tuberculosis
Keywords: Urine-Lam
Diagnostics
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: Umkhuseli Innovation and Research Management (UIRM)
name: University of KwaZulu
name: PATH
name: KwaZulu Natal Department of Health
name: Salus Ltd.
First posted: 2020-10-12
Enrollment: 843
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study may enroll 3 different types of patient cohorts, including (1) hospitalized adults (≥16 years old), (2) ambulatory adults (≥16 years old) in outpatient clinics, and (3) children \<12 years suspected of having active TB disease.

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.


Eligibility 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

Primary outcomes:
measure: Number of Participants Classified with TB Case Definition
timeFrame: Baseline
Secondary outcomes:
measure: Number of Participants with TB Treatment Outcome
timeFrame: 2 Month, 6 Month
Other outcomes:
Locations:
city: Pietermaritzburg
country: South Africa
facility: Edendale Hospital
Study officials:
affiliation: University of Washington
name: Paul K. Drain, MD, MPH, FACP
role: PRINCIPAL_INVESTIGATOR
affiliation: University of KwaZulu
name: Douglas Wilson, MD
role: PRINCIPAL_INVESTIGATOR
References: