Evaluating the Accuracy of New Tests for TB Infection Diagnosis
Launched by FREUNDESKREIS FÜR INTERNATIONALE TUBERKULOSEHILFE E.V · Jan 15, 2024
Trial Information
Current as of July 30, 2025
Completed
Keywords
ClinConnect Summary
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 by 2050, at least one-quarter of the global population living with TB infection would require TB preventive therapy (TPT).
The Tuberculin Skin Test (TST) and Interferon-Gamma Release Assays (IGRA) are the two preferred diagnostic methods for detecting TB infection. TST utilizes Tuberculin PPD RT 23 intradermally, which is low-cost and can easily be performed in the field. TST is currently the...
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- * 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 Criteria:
- * 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).
About Freundeskreis Für Internationale Tuberkulosehilfe E.V
Freundeskreis für Internationale Tuberkulosehilfe e.V. is a dedicated non-profit organization focused on combating tuberculosis (TB) through innovative research, community outreach, and international collaboration. Committed to enhancing global health, the organization sponsors clinical trials aimed at developing effective diagnostic tools, treatment methodologies, and preventive strategies for TB. Leveraging partnerships with healthcare institutions and research entities, Freundeskreis promotes evidence-based practices to improve patient outcomes and reduce the burden of tuberculosis worldwide. Their holistic approach encompasses education, advocacy, and support for affected communities, underscoring their mission to eliminate TB as a public health threat.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Ha Noi, , Vietnam
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported