Latent Infection Freshmen Tracking for Tuberculosis
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age14-24
SponsorAffiliated Hospital of Nantong University
About this trial
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
This trial accepts healthy volunteersQualifiers
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)
Disqualifiers
Presence of active TB at baseline screening
Voluntary receipt of Vaccae vaccination (for the target cohort)
Trial design
Design model
Parallel
Treatments tested in this trial
tuberculosis preventive treatment
Drug3HR Regimen: Isoniazid (INH) + Rifampin (RIF), once daily, 90 total doses (3 months); 3H2P2 Regimen: Isoniazid (INH) + Rifapentine (RPT), twice weekly, 24 total doses (3 months)
Treatment groups
3,000 Participants
are divided into 2 treatment groupsGroup A: TPT GroupActive comparator 1 intervention
Group B: No-TPT GroupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Incident active tuberculosis
Incidence of newly diagnosed active tuberculosis (pulmonary or extrapulmonary) occurring during the 4-year prospective follow-up period among eligible study participants. Active TB cases were systematically tracked and confirmed through three integrated surveillance pathways managed by school health services: routine annual campus health evaluations; symptomatic student self-reports and clinical evaluations at campus health centers; linkage with the national electronic TB surveillance system managed by local CDC. Diagnosis was established per national school TB guidelines. Confirmed active TB required clinical/radiological findings with microbiological/molecular confirmation (M. tuberculosis culture, AFB smear, or GeneXpert MTB/RIF). Bacteriologically negative cases were diagnosed based on chest radiography, persistent symptoms, antibiotic non-responsiveness, and expert consensus.
Time frame
Up to 4 years post-baseline screening (from T0 through August 31, 2026)Sponsors and contacts
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Affiliated Hospital of Nantong University
Lead sponsor
Meishan Municipal Center for Disease Prevention and Control
Collaborator
Source ClinicalTrials.gov