Status:
RECRUITING
Rapid Research in Diagnostics Development for TB Network (R2D2 Kids) and Assessing Diagnostics At POC for TB in Children (ADAPT for Kids)
Lead Sponsor:
University of California, San Francisco
Collaborating Sponsors:
Instituto Nacional de Saúde, Mozambique
National Referral Hospital
Conditions:
Tuberculosis
Diagnostics
Eligibility:
All Genders
Up to 65 years
Phase:
NA
Brief 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 f...
Detailed Description
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 will rigorously assess pro...
Eligibility Criteria
Inclusion
- 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:
- Completed preventive 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 for any reason for greater than 3 days at the time of enrollment (to reduce false-negatives);
- Are unable to return for follow-up visits; or
- 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.
Exclusion
Key Trial Info
Start Date :
January 26 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2026
Estimated Enrollment :
2100 Patients enrolled
Trial Details
Trial ID
NCT05989802
Start Date
January 26 2024
End Date
September 1 2026
Last Update
March 13 2025
Active Locations (3)
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1
Instituto Nacional de Saúde
Maputo, Mozambique
2
Dora Nginza Hospital
Cape Town, South Africa
3
Mulago National Referral Hospital
Kampala, Uganda