Health Trials

Assessing Diagnostics At Point-of-care for Tuberculosis

ConditionTuberculosis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age12+
SponsorUniversity of California, San Francisco

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

1,350 Participants
are divided into 1 treatment group
Group A: Evaluation of various novel TB triage and diagnostic testsExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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)

Time frame
2 years
2

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)

Time frame
2 years

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of California, San Francisco

Lead sponsor

University Hospital Heidelberg

Collaborator

KNCV Tuberculosis Foundation

Collaborator

Bingham University

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

Source ClinicalTrials.gov
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