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

Launched by UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · Aug 9, 2023

Keywords

ClinConnect Summary

The R2D2 Kids and ADAPT for Kids trials are studying new and better ways to diagnose tuberculosis (TB) in children under 15 years old. TB is a serious disease that can lead to many childhood deaths each year, and there is a need for faster and simpler tests that can be used in many places. The goal of these studies is to evaluate new TB tests that are easier to use and less expensive, so that more children can get diagnosed and treated quickly.

To participate, children need to have certain symptoms, like a persistent cough, weight loss, or fever lasting more than two weeks, among others. They should not have received TB treatment in the past year or taken specific medications that might affect the test results. Participants can expect to undergo some tests at local clinics, and their health will be monitored closely during the study. Additionally, healthcare workers involved in the testing will also be part of the study to help assess how well the new TB tests work in real-life situations.

Gender

ALL

Eligibility criteria

• Participant eligibility criteria:
• Participants will include children (age \<15 years) who present to care with:
• A. 2 or more of the following:
• • Unexplained cough for any duration
• • TB contact or tuberculin skin test or interferon gamma release assay positive
• • Abnormal chest X-ray (any abnormality) OR
• B. Any one of criteria A AND any one of the following:
• • Unexplained weight loss OR unexplained failure to thrive OR Severe Acute Malnutrition
• • Unexplained fever ≥2 weeks
• • Unexplained lethargy or reduced playfulness ≥2 weeks
• The study will exclude participants who:
• • 1. Completed preventive 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 for any reason for greater than 3 days at the time of enrollment (to reduce false-negatives);
• • 3. Are unable to return for follow-up visits; or
• • 4. Whose parents/guardians are unwilling to provide informed consent or who are unwilling to provide assent if applicable (age determined by local IRB)
• Assessment of the usability of novel TB tests:
• • The study will also 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). Personnel who are unwilling to provide informed consent will be excluded.