New diagnostic methods for pediatric tuberculosis in Bolivia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.