Status:
RECRUITING
Diagnostic Innovations for Pediatric Tuberculosis in Bolivia
Lead Sponsor:
Tulane University
Collaborating Sponsors:
Asociacion Benefica Prisma
Universidad Peruana Cayetano Heredia
Conditions:
Tuberculosis
Eligibility:
All Genders
2-14 years
Brief Summary
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 chi...
Detailed Description
Pediatric subject populations, enrollment, and follow-up: During the first two years of the study, a "test population" will be recruited for 18 months to establish quantitative cfDNA standards and ran...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 15 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
October 1 2028
Estimated Enrollment :
1220 Patients enrolled
Trial Details
Trial ID
NCT06113861
Start Date
April 15 2024
End Date
October 1 2028
Last Update
September 5 2025
Active Locations (1)
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1
Hospital de Ninos "Mario Ortiz Suarez"
Santa Cruz, Bolivia