Health Trials

Rapid Research in Diagnostics Development for TB Network (R2D2 Kids) and Assessing Diagnostics At POC for TB in Children (ADAPT for Kids)

ConditionsTuberculosisDiagnosticsGlobal Health
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeUp to 65
SponsorUniversity of California, San Francisco

About this trial

Every year there are an estimated 230,000 childhood deaths from TB. There is an urgent need for novel tests for TB diagnosis in children under 15 years. The Rapid Research in Diagnostics Development for TB Network (R2D2 Kids) and the Assessing Diagnostics at Point-of-care for Tuberculosis in children (ADAPT for Kids) studies seek to reduce the burden of TB worldwide by evaluating faster, simpler, and less expensive TB triage and diagnostic tests for use in children.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Unexplained cough for any duration

TB contact or tuberculin skin test or interferon gamma release assay positive

Abnormal chest X-ray (any abnormality) OR

Unexplained weight loss OR unexplained failure to thrive OR Severe Acute Malnutrition

Disqualifiers

None

Trial design

Design model

Single group

Treatments tested in this trial

  • Oral swab molecular testing

    Diagnostic test

    Swab-based testing provides a non-invasive approach to collect respiratory specimens for TB testing. Data in adults suggests that swab-based testing could be valuable when sputum collection is not feasible or available.

  • Automated Cough Sound Analysis

    Diagnostic test

    Cough sounds can be collected through a mobile phone and tablet, and then analyzed with machine learning algorithms to predict TB.

  • Automated Lung Sound Analysis

    Diagnostic test

    Lung sounds can be collected with a non-invasive digital stethoscope, and then saved on a tablet or phone and analyzed by machine learning algorithms to predict TB.

  • Chest X Ray Computer Aided Detection

    Other intervention

    Several artificial intelligence algorithms have been developed to predict TB, though this has not yet been validated in children.

Treatment groups

2,100 Participants
are divided into 1 treatment group
Group A: Evaluation of various novel TB triage and diagnostic testsExperimental treatment 4 interventions

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

Instituto Nacional de Saúde, Mozambique

Collaborator

National Referral Hospital

Collaborator

University of Cape Town

Collaborator

Johns Hopkins University

Collaborator

Elizabeth Glaser Pediatric AIDS Foundation

Collaborator

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborator

University of California, Irvine

Collaborator

Source ClinicalTrials.gov
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