Status:
COMPLETED
Evaluating the Accuracy of New Tests for TB Infection Diagnosis
Lead Sponsor:
Freundeskreis Für Internationale Tuberkulosehilfe e.V
Conditions:
Latent Tuberculosis
TB Infection
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Introduction: The large reservoir of tuberculosis infections is a key driver of sustained tuberculosis (TB) incidence. Accurate diagnostic tests are crucial to correctly identify and treat people with...
Detailed Description
Latent TB infection, hereafter referred to as TB infection, continues to be a significant driver of the global TB burden. A recent re-estimation using mathematical modeling demonstrated that to end TB...
Eligibility Criteria
Inclusion
- All participants:
- Agree to remain in contact and provide updated information as necessary, and have no current plans to relocate outside the designated area for the duration of the study
- Capable of providing signed informed consent and informed assent (as appropriate)
- Group 1:
- \+ Microbiologically-confirmed pulmonary TB (either drug-susceptible TB or drug-resistant TB) via Xpert MTB/RIF or Xpert MTB/RIF Ultra (Cepheid, Sunnyvale, California) and abnormal chest X-ray (CXR) result\*
- \*To reduce the false positive rate of molecular diagnostic assays for M. tuberculosis
- Group 2:
- \+ Household contacts without symptoms of active TB disease of people with microbiologically-confirmed, pulmonary TB who initiated treatment with residents in Ha Noi, Vietnam.
- Group 3:
- Known past negative IGRA test results among those at low risk for TB infection
- No known and/or reported history of contact or exposure to either TB disease or M. tuberculosis bacteria.
Exclusion
- All participants:
- \+ Declines to provide informed consent to participate in the study
- Groups 2 \&3:
- Presumed TB disease with symptoms (cough, fever, night sweats, unintentional weight loss) and/or an abnormal CXR result suggestive of TB disease
- Microbiologically - or clinically-confirmed TB disease in all forms or report having taken treatment for TB disease.
- History of TB infection (self-record or documented).
Key Trial Info
Start Date :
June 11 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2024
Estimated Enrollment :
352 Patients enrolled
Trial Details
Trial ID
NCT06221735
Start Date
June 11 2024
End Date
December 31 2024
Last Update
March 19 2025
Active Locations (1)
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1
Vietnam National Lung Hospital
Hà Nội, Vietnam, 10000