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Study identifier: NCT06113861 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

Diagnostic Innovations for Pediatric Tuberculosis in Bolivia

Condition: Tuberculosis  ·  Sponsor: Tulane University

PhaseN/A
Planned participants1220
Who can joinAll sexes, 2 Months to 14 Years
Healthy volunteersNo

About this study

Pediatric tuberculosis (TB) continues to pose diagnostic challenges in low- and middle-income countries with high rates of TB disease, due to the well-described impact of paucibacillary disease in children, and current TB culture and polymerase-chain reaction tests are of limited usefulness due to cost, restricted availability, and poor sensitivity in specimens available from younger children. Our team of experts from Tulane, Johns Hopkins University, Universidad Peruana Cayetano Heredia, and Asociación Benéfica Prisma have confronted all of these challenges through more than 25 years of collaboration in Peru and Bolivia. Our goal is to directly address the challenges of TB in children by evaluating a new diagnostic approach developed by MPI Tony Hu at Tulane University using a CRISPR-mediated TB assay (CRISPR-TB) optimized to detect circulating Mycobacterium tuberculosis cell-free DNA (Mtb-cfDNA), and used to analyze cryopreserved serum in pilot studies from adults and children with presumptive TB, their asymptomatic household contacts, and a cohort of symptomatic children living with HIV (CLHIV) at high risk for TB. Results from symptomatic adult cohorts yielded a pooled sensitivity of 93%; specificity of 93%; positive predictive value of 95%; and negative predictive value of 92%. In limited pilot studies in CLHIV CRISPR-TBD results accurately identified all confirmed TB (13/13) and most children with unconfirmed TB (80%; 52/65). We propose to enroll 200 presumptive TB case…

This description comes directly from the study's public registry record.

Talk to the study team

Richard Oberhelman, MD  ·  001-504-952-0964  ·  oberhel@tulane.edu

Always discuss trial participation with your own doctor first.

Locations (1)

Hospital de Ninos "Mario Ortiz Suarez"Santa Cruz, BoliviaRecruiting

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Source record: clinicaltrials.gov/study/NCT06113861