Evaluating New Diagnostic Tests for Pediatric Tuberculosis in Children Ages 2 Months to 14 Years in Bolivia

What this Trial Is About

Researchers are exploring new ways to diagnose tuberculosis TB in children, focusing on populations in Bolivia. Pediatric TB is difficult to detect because current tests often miss cases, especially in young children, due to limited sensitivity and availability. This study evaluates a novel blood test using CRISPR technology to detect TB DNA in the blood, aiming to better identify both confirmed and unconfirmed TB cases. The research involves children from 2 months to 14 years old, including those with symptoms suggestive of TB and well children as controls. The study is observational and includes two main groups a test population and a validation population, each enrolling about 200 children with suspected TB and matched healthy controls. Children are grouped by TB status confirmed, unconfirmed, unlikely and age 2 months to 6 years, 7 to 14 years. Participants undergo diagnostic tests including blood tests for TB and HIV, chest X-rays, lung ultrasounds, and sputum or gastric samples for TB cultures. Serial blood samples will be collected over time to measure TB DNA levels, especially among those receiving TB treatment. Participants will have medical history reviews, physical exams, and various diagnostic procedures at enrollment and follow-up visits at 1 week, 2 weeks, and 2 months after starting treatment if diagnosed with TB. Imaging results will be analyzed using computer-aided and machine learning methods to correlate with blood test findings. The main outcome measured is the level of TB DNA in blood at the start and after treatment. The study helps assess whether combining these new tests can improve TB diagnosis in children, particularly in low-resource settings. Total participation varies depending on group and follow-up needs.

Diagnostic Innovations for Pediatric Tuberculosis in Bolivia