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NCT06221735: TB infection
Evaluating the Accuracy of New Tests for TB Infection Diagnosis
NA trial testing Cy-TB test in Latent Tuberculosis in 352 participants. Completed in 31 December 2024.
31 December 2024
Quick facts
| Lead sponsor | Freundeskreis Für Internationale Tuberkulosehilfe e.V |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | diagnostic |
| Enrollment | 352 |
| Start date | 11 June 2024 |
| Primary completion | 31 December 2024 |
| Estimated completion | 31 December 2024 |
| Sites | 1 location across Vietnam |
Drugs / interventions tested
- Cy-TB test
- STANDARD F TB-Feron FIA test
Conditions studied
- Latent Tuberculosis — all drugs for Latent Tuberculosis →
- TB Infection — all drugs for TB Infection →
- Tuberculosis — all drugs for Tuberculosis →
Sponsor
Freundeskreis Für Internationale Tuberkulosehilfe e.V
Who can join
18 and older, any sex, with Latent Tuberculosis or TB Infection. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT06221735
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Related trials
Other recruiting trials for Latent Tuberculosis
Currently open trials in the same condition.
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- NCT06022146 — TB YOUTH - TB sYstemic Management Using One-month, Ultra-short TPT Regimen for scHool Contacts · Phase 3 · recruiting
- NCT05411744 — One-month Latent Tuberculosis Treatment for Renal Transplant Candidates · Phase 4 · active not recruiting
- NCT05412212 — Brief Educational Video for Patients Prescribed LTBI Treatment · NA · active not recruiting
- NCT05022862 — Economic Incentives and vDOT for Latent Tuberculosis Infection · NA · recruiting
Other Freundeskreis Für Internationale Tuberkulosehilfe e.V trials
Trials by the same sponsor.
- NCT06191692 — 1HP Versus 3HR in the Treatment of Tuberculosis Infection in Vietnam · Phase 3 · not yet recruiting
- NCT06916962 — Examining Psycho-Socioeconomic Linkages in TB Care: The UPLIFT Trial · NA · recruiting
- NCT06401434 — Evaluation of CAD-based Triage for CXR Interpretation During TB Screening · NA · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06221735 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Freundeskreis Für Internationale Tuberkulosehilfe e.V
- Last refreshed: 19 March 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06221735.
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