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Assessing Diagnostics At Point-of-care for Tuberculosis (ADAPT)

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ClinicalTrials.gov Identifier: NCT05941052
Recruitment Status : Recruiting
First Posted : July 12, 2023
Last Update Posted : September 22, 2023
Sponsor:
Collaborators:
University Hospital Heidelberg
KNCV Tuberculosis Foundation
Bingham University
University of California, Irvine
De La Salle University Medical Center
Centre for Infectious Disease Research in Zambia
Johns Hopkins University
Information provided by (Responsible Party):
University of California, San Francisco

Study Description
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Brief Summary:
Every year, more than 3 million people with TB remain undiagnosed and 1 million die. Better diagnostics are essential to reducing the enormous burden of TB worldwide. The Assessing Diagnostics At Point-of-care for Tuberculosis (ADAPT) study seeks to reduce the burden of TB worldwide by evaluating faster, simpler, and less expensive TB triage and diagnostic tests.

Condition or disease Intervention/treatment Phase
Tuberculosis Diagnostic Test: Tongue swab-based molecular assays Not Applicable

Detailed Description:
The Assessing Diagnostics At Point-of-care for Tuberculosis (ADAPT) seeks to identify and rigorously assess promising, design-locked point-of-care (POC) tuberculosis (TB) diagnostic tests (hereafter referred to as "novel tests") in clinical studies conducted in settings of intended use. Rapid diagnosis and effective treatment are critical for improving patient outcomes and reducing TB transmission. However, nearly one-third of people with TB are not diagnosed or reported to public health authorities.The different types of tests required to reduce this "diagnostic gap" have been described in the form of target product profiles (TPPs) defined by the World Health Organization (WHO). The highest priority TPP is that for a point-of-care, non-sputum biomarker-based test to facilitate rapid TB diagnosis using easily accessible samples (i.e., a biomarker-based diagnostic test). The ADAPT study will evaluate the sensitivity, specificity and yield of novel diagnostic tests against a reference standard including sputum Xpert® Mycobacterium tuberculosis/Rifampicin (MTB/RIF) Ultra and sputum mycobacterial culture among adolescents and adults with presumptive TB (based on having TB symptoms, or TB risk factor + positive TB screening test) presenting to outpatient health facilities in high burden countries. In addition, the usability and acceptability of novel TB diagnostic tests will be assessed through direct observations and surveys of routine health workers.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1350 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Supporting, Mobilizing and Accelerating Research for Tuberculosis Elimination (SMART4TB)- Technical Area (TA) 1: Diagnostics- Assessing Diagnostics At Point-of-care for Tuberculosis (ADAPT)
Actual Study Start Date : August 28, 2023
Estimated Primary Completion Date : September 30, 2028
Estimated Study Completion Date : September 30, 2028

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tuberculosis

Arms and Interventions
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Arm Intervention/treatment
Experimental: Evaluation of various novel TB triage and diagnostic tests
For the novel TB triage and diagnostic tests, the investigators will conduct large-scale evaluation of design-locked tests in a cohort of adults with presumed TB. The investigators aim to enroll 450 participants per year at each of three enrollment sites for evaluation of various novel TB triage and diagnostic tests and 50 health workers to assess test usability.
 Diagnostic Test: Tongue swab-based molecular assays
The investigators will evaluate semi-automated or automated molecular assays intended for use at near point of care or point of care.


Outcome Measures
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Primary Outcome Measures :
  1. Proportion with positive index test result among participants with tuberculosis (TB) [ Time Frame: 2 years ]
    Sensitivity - Number with positive index test result/(Number with positive or negative index t test result) among participants with TB. TB will be defined based on a microbiological reference standard (sputum mycobacterial culture results)

  2. Proportion with negative index test result among participants without tuberculosis (TB) [ Time Frame: 2 years ]
    Specificity - Number with negative index test results/(Number with positive or negative index t test result) among participants without TB. TB will be defined based on a microbiological reference standard (sputum mycobacterial culture results)


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Novel TB triage and diagnostic tests:

Inclusion Criteria-

The investigators will include non-hospitalized adults (age ≥ 12 years) with either:

  1. cough ≥2 weeks' duration, a commonly accepted criterion for identifying people with presumed pulmonary TB (to facilitate standardization across sites and comparison of test performance across sub-groups; OR
  2. risk factors for which TB screening is recommended (HIV infection, self-reported close contact, history of mining work). People with risk factors will be included if they screen positive for TB based on WHO-recommended screening tools as specified below:

Positive TB screening definitions by risk factor:

  1. People Living with Human Immunodeficiency Virus (PLHIV) (Risk Factor): C Reactive Protein (CRP) >5 mg/dL OR abnormal chest x-ray (CXR)
  2. Self-reported Close Contact (Risk Factor): abnormal CXR History of mining work (Risk Factor): abnormal CXR

Exclusion Criteria-

  1. Completed latent or active TB treatment within the past 12 months (to increase TB prevalence and reduce false-positive results, respectively);
  2. Have taken any medication with anti-mycobacterial activity (including fluoroquinolones) for any reason, within 2 weeks of study entry (to reduce false-negatives);
  3. Reside >20km from the study site or are unwilling to return for follow-up visits; OR
  4. Are unwilling to provide informed consent

Assessment of the usability of novel TB tests:

Inclusion Criteria-

The investigators will include health workers at each clinical site who are:

  1. aged ≥18 years; AND
  2. involved in routine TB testing (collecting specimens for or performing TB tests).

Exclusion Criteria-

The investigators will exclude staff who are:

1) unwilling to provide informed consent

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05941052


Contacts
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Contact: Adithya Cattamanchi +1-415-206-5489 adithya.cattamanchi@ucsf.edu
Contact: Catherine Cook 603-988-9940 Catherine.Cook@ucsf.edu

Locations
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Nigeria
Zankli Research Center, Bingham University Recruiting
Abuja, Nigeria
Contact: John Bimba       john.bimba@binghamuni.edu.ng   
Philippines
De La Salle Medical and Health Sciences Institute Recruiting
Dasmariñas, Philippines
Contact: Charles Yu       chrlsyu@yahoo.com   
Zambia
Centre for Infectious Disease Research in Zambia Recruiting
Lusaka, Zambia
Contact: Monde Muyoyeta       monde.muyoyeta@cidrz.org   
Sponsors and Collaborators
University of California, San Francisco
University Hospital Heidelberg
KNCV Tuberculosis Foundation
Bingham University
University of California, Irvine
De La Salle University Medical Center
Centre for Infectious Disease Research in Zambia
Johns Hopkins University
Investigators
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Principal Investigator: Adithya Cattamanchi University of California, Irvine
More Information
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Publications:
World Health Organization. Global tuberculosis report Geneva, Switzerland: World Health Organization, 2015.
Organization WH. High-priority target product profiles for new tuberculosis diagnostics: report of a consensus meeting. Geneva, Switzerland: WHO Press, 2014.

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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT05941052    
Other Study ID Numbers: 7200AA22RFA00004
First Posted: July 12, 2023    Key Record Dates
Last Update Posted: September 22, 2023
Last Verified: September 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by University of California, San Francisco:
Tuberculosis
Diagnostics
Global Health
Additional relevant MeSH terms:
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Tuberculosis
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
 Bacterial Infections
Bacterial Infections and Mycoses
Infections