Assessing Diagnostics At Point-of-care for Tuberculosis

NCT ID: NCT05941052

Last Updated: 2025-08-29

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 1350 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-28
• Study Completion Date: 2028-09-30

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.

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.

Conditions

Tuberculosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Tongue swab-based molecular assays

Intervention Type: DIAGNOSTIC_TEST

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

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

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

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:

The investigators will exclude staff who are:

1) unwilling to provide informed consent

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

Sponsors

University Hospital Heidelberg

OTHER

Sponsor Role: collaborator

KNCV Tuberculosis Foundation

OTHER

Sponsor Role: collaborator

Bingham University

UNKNOWN

Sponsor Role: collaborator

University of California, Irvine

OTHER

Sponsor Role: collaborator

De La Salle University Medical Center

OTHER

Sponsor Role: collaborator

Centre for Infectious Disease Research in Zambia

OTHER

Sponsor Role: collaborator

Johns Hopkins University

OTHER

Sponsor Role: collaborator

University of California, San Francisco

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Adithya Cattamanchi

Role: PRINCIPAL_INVESTIGATOR

University of California, Irvine

Locations

Zankli Research Center, Bingham University

Abuja, , Nigeria

Site Status: RECRUITING

De La Salle Medical and Health Sciences Institute

Dasmariñas, , Philippines

Site Status: RECRUITING

Centre for Infectious Disease Research in Zambia

Lusaka, , Zambia

Site Status: RECRUITING

Countries

Nigeria; Philippines; Zambia

Central Contacts

Adithya Cattamanchi

Role: CONTACT

adithya.cattamanchi@ucsf.edu

+1-415-206-5489

Catherine Cook

Role: CONTACT

Catherine.Cook@ucsf.edu

603-988-9940

Facility Contacts

John Bimba

Role: primary

john.bimba@binghamuni.edu.ng

Charles Yu

Role: primary

chrlsyu@yahoo.com

Monde Muyoyeta

Role: primary

monde.muyoyeta@cidrz.org

References

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.

Reference Type: BACKGROUND

PMID: 17584529 (View on PubMed)

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

Reference Type: BACKGROUND

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

Reference Type: 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.

Reference Type: BACKGROUND

PMID: 20825313 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24172543 (View on PubMed)

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/

Reference Type: BACKGROUND

PMID: 25473699 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 27780217 (View on PubMed)

Other Identifiers

7200AA22RFA00004

Identifier Type: -

Identifier Source: org_study_id