Evaluating new TB diagnostic tests for children

Rapid Research in Diagnostics Development for Tuberculosis Network (R2D2 Kids) and Assessing Diagnostics At Point-of-care for Tuberculosis in Children (ADAPT for Kids)

This study is testing new, easier ways to diagnose tuberculosis in children under 15 to help them get treated faster and reduce the risk of serious illness.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 2100 (estimated)
• Ages: N/A to 65 Years
• Sex: All
• Sponsor: University of California, San Francisco (Academic / other)
• Locations: 3 sites (Maputo and 2 other locations)
• Trial ID: NCT05989802 on ClinicalTrials.gov

What this trial studies

This study aims to assess novel, point-of-care diagnostic tests for tuberculosis (TB) in children under 15 years old. Given the challenges of obtaining sputum samples and the low bacillary burden in pediatric TB cases, the study will evaluate non-sputum biomarker-based tests that could facilitate faster diagnosis and treatment. The research will involve clinical assessments of the sensitivity and specificity of these tests, as well as their usability and acceptability among healthcare workers. The goal is to reduce the high mortality rate associated with childhood TB by providing simpler and more effective diagnostic tools.

Who should consider this trial

Good fit: Ideal candidates for this study are children under 15 years who present with symptoms suggestive of TB, such as unexplained cough, weight loss, or fever.

Not a fit: Patients who have recently completed TB treatment or are currently on anti-mycobacterial medication may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to quicker and more accurate TB diagnoses in children, potentially saving lives.

How similar studies have performed: Other studies have shown promise in developing rapid diagnostic tests for TB, but this specific approach focusing on children is relatively novel.

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.

Where this trial is running

Maputo and 2 other locations

• Instituto Nacional de Saúde — Maputo, Mozambique (Recruiting)
• Dora Nginza Hospital — Cape Town, South Africa (Not_yet_recruiting)
• Mulago National Referral Hospital — Kampala, Uganda (Not_yet_recruiting)

Study contacts

• Principal investigator: Adithya Cattamanchi, MD, MAS — University of California, Irvine
• Study coordinator: Devan Jaganath, MD

Conditions Tuberculosis; Diagnostics; Global Health