NCT06221735Completed
Evaluating the Accuracy of New Tests for TB Infection Diagnosis
Source: ClinicalTrials.gov · Last updated 19 Mar 2025
Brief summary (registry, in English)
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 TB infection, which is vital to eliminate TB globally. The Cy-TB skin test and STANDARD F TB-Feron FIA (TB-Feron) fluorescent immunoassay are two newly developed TB infection tests, which could offer quality and cost advantages over other commercially available TB infection tests, especially the standard TST test. Both tests have a higher sensitivity and specificity than the currently most used tuberculin skin test. The proposed study aims to evaluate the performance of these two tests for the diagnosis of TB infection, compared with the QuantiFERON-TB Gold Plus (QFT-Plus) assay. Methods and analysis: This diagnostic accuracy study will employ a cross-sectional, observational design that aims to assess the accuracy of the Cy-TB and TB-Feron tests for diagnosing TB infection, using the QFT-Plus assay as the reference standard. The sensitivity and specificity will be reported. Three different cohorts of study participants will be recruited: Adults with microbiologically-confirmed pulmonary TB (n=100); Household contacts\* of people with TB (n=200) and negative controls\*\* (n=50). All participants will be examined with Cy-TB, TB-Feron, and QFT-Plus. \*Household contacts: of a person with TB are defined as members who live under the same roof as the person with pulmonary tuberculosis (PTB) or who meet the following conditions: * Sleeping under the same roof or sharing a kitchen space as PTB-affected persons at least one night/week for three months before the person was diagnosed with PTB * Staying under the same roof with PTB-affected persons for at least one hour/day and continuously five days/week for three months before the person was diagnosed with PTB * Negative controls are defined as people with a negative QFT-Plus result in the past year and likely to have no or very low rates of TB exposure history.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 352 (actual)
- First submitted
- 15 Jan 2024
- Start date
- 11 Jun 2024
- Primary completion date
- 31 Dec 2024
- Lead sponsor
- Freundeskreis Für Internationale Tuberkulosehilfe e.V
- Diseases
- Tuberculosis
- NCT number
- NCT06221735
What you commit to
- Study type: Interventional
- Participants enrolled: 352
- From 11 Jun 2024 to the primary completion date, 31 Dec 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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).
Other
- All participants:
- \+ Declines to provide informed consent to participate in the study
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Vietnam National Lung Hospital Coordinator of this site? Confirm its status | Hà Nội | Vietnam | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.