NCT07811518 Latent Infection Freshmen Tracking for Tuberculosis
| NCT ID | NCT07811518 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Affiliated Hospital of Nantong University |
| Condition | Latent Tuberculosis Infection (LTBI) |
| Study Type | INTERVENTIONAL |
| Enrollment | 3,000 participants |
| Start Date | 2022-08-15 |
| Primary Completion | 2026-08-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 3,000 participants in total. It began in 2022-08-15 with a primary completion date of 2026-08-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this study is to learn whether taking short-course preventive treatment in high school and college freshmen with strong positive tuberculosis (TB) skin tests can safely and effectively protect them from developing active TB over a 3-to-4-years period. Main question: Does taking short-course preventive treatment reduce the risk of active TB in freshmen who have strong positive TB skin tests? All freshmen across 26 schools in Meishan City, Sichuan Province, China were screened for TB. Among them, the students with strong positive skin tests (indicating latent TB infection) and no active disease entered the study. Students voluntarily chose to either take a 3-month short-course preventive treatment under campus medical supervision or receive routine health observation without medication. Researchers tracked all participants for 3 to 4 years to monitor who developed active TB and evaluate the treatment's safety and effectiveness.
Eligibility Criteria
Inclusion Criteria: * Matriculating freshmen aged 14-24 years enrolled across 26 participating educational institutions * Completion of baseline tuberculosis screening, including systematic symptom screening, digital chest radiography, and tuberculin skin test (TST) * Target cohort requirement: TST strong reactivity (induration ≥15 mm or severe local reactions such as blisters, necrosis, or lymphangitis) with active TB ruled out at baseline * Control cohort requirement: TST induration \<15 mm (including negative \<5 mm, weakly positive 5-9 mm, and moderately positive 10-14 mm) Exclusion Criteria: * Presence of active TB at baseline screening * Voluntary receipt of Vaccae vaccination (for the target cohort)
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07811518 clinical trial?
This trial is open to participants of all sexes, aged 14 Years or older, up to 24 Years, studying Latent Tuberculosis Infection (LTBI). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07811518 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07811518 currently recruiting?
Yes, NCT07811518 is actively recruiting participants. Contact the research team at tonygqin@ntu.edu.cn for enrollment information.
Where is the NCT07811518 trial being conducted?
This trial is being conducted at Nantong, China, Meishan, China.
Who is sponsoring the NCT07811518 clinical trial?
NCT07811518 is sponsored by Affiliated Hospital of Nantong University. The trial plans to enroll 3,000 participants.