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

Summary

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.

Conditions

• Tuberculosis
• Diagnostics
• Global Health

Interventions

DIAGNOSTIC_TEST

Oral swab molecular testing

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.

DIAGNOSTIC_TEST

Automated Cough Sound Analysis

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

DIAGNOSTIC_TEST

Automated Lung Sound Analysis

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.

OTHER

Chest X Ray Computer Aided Detection

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

Sponsors & Collaborators

• Instituto Nacional de Saúde, Mozambique

  collaborator OTHER_GOV

• National Referral Hospital

  collaborator OTHER_GOV

• University of Cape Town

  collaborator OTHER

• Johns Hopkins University

  collaborator OTHER

• Elizabeth Glaser Pediatric AIDS Foundation

  collaborator OTHER

• National Institute of Allergy and Infectious Diseases (NIAID)

  collaborator NIH

• University of California, Irvine

  collaborator OTHER

• University of California, San Francisco

  lead OTHER

Principal Investigators

• Adithya Cattamanchi, MD, MAS · University of California, Irvine

• Nilesh Bhatt · Elizabeth Glazer Pediatric AIDS Foundation

Study Design

Allocation

NA

Purpose

DIAGNOSTIC

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Max Age

65 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2024-01-26

Primary Completion

2026-09-01

Completion

2026-09-01

FDA Device

Yes

Countries

• Mozambique
• South Africa
• Uganda

Study Locations