New diagnostic methods for pediatric tuberculosis in Bolivia
Diagnostic Innovations for Pediatric Tuberculosis in Bolivia
This study is testing a new blood test to see if it can help doctors better diagnose tuberculosis in children in Bolivia.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1220 (estimated) |
| Ages | 2 Months to 14 Years |
| Sex | All |
| Sponsor | Tulane University Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Santa Cruz) |
| Trial ID | NCT06113861 on ClinicalTrials.gov |
What this trial studies
This study aims to improve the diagnosis of pediatric tuberculosis (TB) in Bolivia by evaluating a novel CRISPR-mediated assay that detects Mycobacterium tuberculosis cell-free DNA in serum samples. Over the first two years, a test population of children aged 2 months to 14 years will be recruited to establish cfDNA standards and assess its predictive value as a biomarker for TB outcomes. In the subsequent years, a validation population will be recruited to confirm these standards and analyze cfDNA levels in relation to TB treatment effectiveness. The study will focus on two age groups to account for differences in diagnostic yield and clinical presentation.
Who should consider this trial
Good fit: Ideal candidates for this study are children aged 2 months to 14 years who are presenting with symptoms of respiratory disease and suspected tuberculosis.
Not a fit: Patients who have received prior treatment for TB within the past year or are currently undergoing TB prevention treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more accurate and accessible diagnostic methods for pediatric tuberculosis, improving early detection and treatment outcomes.
How similar studies have performed: Other studies have shown promise in using innovative diagnostic approaches for tuberculosis, but this specific CRISPR-mediated method is novel and untested in this population.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Children presenting for evaluation for symptomatic respiratory disease and suspicion of tuberculosis will be eligible for enrollment (inclusion criteria based on Bolivian Ministry of Health guidelines for suspect cases of tuberculosis in children Exclusion Criteria: * prior treatment for TB within the past year, * current treatment for prevention of TB, * weight \< 2.5 kg., or * clinical instability, * positive COVID-19 diagnostic test
Where this trial is running
Santa Cruz
- Hospital de Ninos "Mario Ortiz Suarez" — Santa Cruz, Bolivia (Recruiting)
Study contacts
- Study coordinator: Richard Oberhelman, MD
- Email: oberhel@tulane.edu
- Phone: 001-504-952-0964
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.