Assessing Diagnostics At Point-of-care for Tuberculosis

NCT05941052 | Recruiting FDA Device

• 1 other identifier: 7200AA22RFA00004
• Study Type: interventional
• Target: 1,350
• Locations: 3 countries
• Sites: 3

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.

Conditions

Tuberculosis

Keywords

Tuberculosis; Diagnostics; Global Health

Outcome Measures

Primary Outcomes (2)

• Proportion with positive index test result among participants with tuberculosis (TB)

  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 years

• Proportion with negative index test result among participants without tuberculosis (TB)

  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)

  2 years

Study Arms (1)

Evaluation of various novel TB triage and diagnostic tests

EXPERIMENTAL

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

Interventions

Tongue swab-based molecular assays DIAGNOSTIC_TEST

The investigators will evaluate semi-automated or automated molecular assays intended for use at near point of care or point of care.

Evaluation of various novel TB triage and diagnostic tests

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• The investigators will include non-hospitalized adults (age ≥ 12 years) with either:
• 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
• 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:
• People Living with Human Immunodeficiency Virus (PLHIV) (Risk Factor): C Reactive Protein (CRP) \>5 mg/dL OR abnormal chest x-ray (CXR)
• Self-reported Close Contact (Risk Factor): abnormal CXR History of mining work (Risk Factor): abnormal CXR

You may not qualify if:

• Completed latent or active TB treatment within the past 12 months (to increase TB prevalence and reduce false-positive results, respectively);
• Have taken any medication with anti-mycobacterial activity (including fluoroquinolones) for any reason, within 2 weeks of study entry (to reduce false-negatives);
• Reside \>20km from the study site or are unwilling to return for follow-up visits; OR
• Are unwilling to provide informed consent
• Assessment of the usability of novel TB tests:
• The investigators will include health workers at each clinical site who are:
• aged ≥18 years; AND
• involved in routine TB testing (collecting specimens for or performing TB tests).
• The investigators will exclude staff who are:
• \) unwilling to provide informed consent

Sponsors & Collaborators

• Bingham University: collaborator
• University of California, San Francisco: lead
• University Hospital Heidelberg: collaborator
• KNCV Tuberculosis Foundation: collaborator
• University of California, Irvine: collaborator
• De La Salle University Medical Center: collaborator
• Centre for Infectious Disease Research in Zambia: collaborator
• Johns Hopkins University: collaborator

Study Sites (3)

Zankli Research Center, Bingham University

Abuja, Nigeria

RECRUITING

De La Salle Medical and Health Sciences Institute

Dasmariñas, Philippines

RECRUITING

Centre for Infectious Disease Research in Zambia

Lusaka, Zambia

RECRUITING

Related Publications (7)

• Cho SN, Brennan PJ. Tuberculosis: diagnostics. Tuberculosis (Edinb). 2007 Aug;87 Suppl 1:S14-7. doi: 10.1016/j.tube.2007.05.001. Epub 2007 Jun 20.

  PMID: 17584529 BACKGROUND

• World Health Organization. Global tuberculosis report Geneva, Switzerland: World Health Organization, 2015.

  BACKGROUND

• Organization WH. High-priority target product profiles for new tuberculosis diagnostics: report of a consensus meeting. Geneva, Switzerland: WHO Press, 2014.

  BACKGROUND

• Boehme CC, Nabeta P, Hillemann D, Nicol MP, Shenai S, Krapp F, Allen J, Tahirli R, Blakemore R, Rustomjee R, Milovic A, Jones M, O'Brien SM, Persing DH, Ruesch-Gerdes S, Gotuzzo E, Rodrigues C, Alland D, Perkins MD. Rapid molecular detection of tuberculosis and rifampin resistance. N Engl J Med. 2010 Sep 9;363(11):1005-15. doi: 10.1056/NEJMoa0907847. Epub 2010 Sep 1.

  PMID: 20825313 BACKGROUND

• Walusimbi S, Bwanga F, De Costa A, Haile M, Joloba M, Hoffner S. Meta-analysis to compare the accuracy of GeneXpert, MODS and the WHO 2007 algorithm for diagnosis of smear-negative pulmonary tuberculosis. BMC Infect Dis. 2013 Oct 30;13:507. doi: 10.1186/1471-2334-13-507.

  PMID: 24172543 BACKGROUND

• Xpert MTB/RIF Implementation Manual: Technical and Operational 'How-To'; Practical Considerations. Geneva: World Health Organization; 2014. Available from http://www.ncbi.nlm.nih.gov/books/NBK254323/

  PMID: 25473699 BACKGROUND

• Subbaraman R, Nathavitharana RR, Satyanarayana S, Pai M, Thomas BE, Chadha VK, Rade K, Swaminathan S, Mayer KH. The Tuberculosis Cascade of Care in India's Public Sector: A Systematic Review and Meta-analysis. PLoS Med. 2016 Oct 25;13(10):e1002149. doi: 10.1371/journal.pmed.1002149. eCollection 2016 Oct.

  PMID: 27780217 BACKGROUND

MeSH Terms

Conditions

Tuberculosis

Condition Hierarchy (Ancestors)

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

Study Officials

• Adithya Cattamanchi

  University of California, Irvine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Adithya Cattamanchi

CONTACT

+1-415-206-5489; adithya.cattamanchi@ucsf.edu

Catherine Cook

CONTACT

603-988-9940; Catherine.Cook@ucsf.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 3, 2023
• First Posted: July 12, 2023
• Study Start: August 28, 2023
• Primary Completion (Estimated): September 30, 2028
• Study Completion (Estimated): September 30, 2028
• Last Updated: March 9, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

NG (1); PH (1); ZA (1)