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Latent Tuberculosis Infection (LTBI)Phase 4LIFT-TBNCT07811518

Latent Infection Freshmen Tracking for Tuberculosis

A Phase 4 study testing tuberculosis preventive treatment in people with Latent Tuberculosis Infection (LTBI) and Tuberculosis (TB), run by Affiliated Hospital of Nantong University at 2 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 14 to 24 yearsHealthy volunteers can take part
What is being tested?
tuberculosis preventive treatment
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3,000 participants
Where
2 sitesChina
Study dates
15 Aug 2022to 31 Aug 2029
Phase
Phase 4
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 14 to 24 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • 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)

Who cannot join

  • Presence of active TB at baseline screening
  • Voluntary receipt of Vaccae vaccination (for the target cohort)

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Gang Qin, MD, PhD contact

086-189-1228-8106

tonygqin@ntu.edu.cn

Yu Zhang, MBBS contact

086-151-8331-6420

zhangyu_mscdc@163.com

China2 sites, 2 recruiting

  • Meishan Municipal Center for Disease Prevention and Control

    Meishan, Sichuan, 620010

    Yu Zhang, MBBS, 086-028-3819-7429, zhangyu_mscdc@163.com

    Recruiting

  • Affiliated Hospital of Nantong University

    Nantong, Jiangsu, 226001

    Xian Zhang, MD, PhD, 086-513-5231-2490, zhangxian8412@163.com

    Recruiting

Other trials in China

About this study

Official title: Real-World Implementation and Effectiveness of Tuberculosis Preventive Treatment in School Health Services in China

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.

Read the detailed description

The Latent Infection Freshmen Tracking for Tuberculosis (LIFT-TB) study is a prospective, multi-center, real-world implementation cohort designed to evaluate the programmatic feasibility, safety, and long-term effectiveness of school-integrated short-course tuberculosis preventive treatment (TPT) among matriculating freshmen. Embedded within routine campus health services across 26 educational institutions (secondary vocational schools, colleges, and universities) in Meishan City, Sichuan Province, China, the protocol operationalizes proactive case-finding and preventive intervention at student entry.

Screening cascade and baseline stratification Under mandatory institutional biosecurity regulations, all newly enrolled freshmen underwent entry health evaluations comprising tuberculin skin testing (TST with 5 TU PPD-RT23), active symptom screening, and digital chest radiography (CXR). To maximize population coverage (>99%) and minimize non-response bias, a 2-week catch-up window was instituted for students initially absent. To account for widespread neonatal BCG vaccination, baseline infection risk was operationalized using TST induration thresholds.

Control cohort: Students with TST indurations <15 mm (subdivided into TST <5 mm, 5-9 mm, and 10-14 mm).

Target Cohort: Students with strong TST reactivity (≥15 mm or local severe reactions such as blisters/necrosis) in whom active TB was clinically excluded.

Intervention workflows and adherence monitoring Within the target cohort, TPT initiation was managed through shared decision-making. Eligible participants voluntarily initiated one of two WHO-recommended 3-month short-course regimens: Daily fixed-dose combination isoniazid/rifampicin (3HR). Twice-weekly isoniazid plus rifapentine (3H2P2). Treatment administration was embedded within campus health clinics using a hybrid directly observed therapy model combining in-person clinic DOT with smartphone-based video DOT (vDOT). Participants receiving medical observation alone without medication served as the No-TPT comparison group. Adverse events were routinely graded per CTCAE v5.0, with regular safety monitoring to capture potential hepatotoxicity.

Causal inference and emulation framework To complement primary multivariate Cox proportional hazards modeling and address observational confounding inherent in non-randomized treatment assignment, the analytic workflow incorporated a Target Trial Emulation (TTE) framework as sensitivity analyses. Time zero (T0) was anchored to the date of LTBI eligibility confirmation, incorporating a 14-day grace period to align baseline entry and eliminate immortal time bias. High-dimensional baseline covariates, including demographic factors, BMI, school type, medical major, BCG status, prior TB history, and close contact history, were balanced using 1:1 Propensity Score Matching (PSM) and Inverse Probability of Treatment Weighting (IPTW with stabilized weights) to estimate the Average Treatment Effect on the Treated (ATT) across both modified intention-to-treat (mITT) and per-protocol (PP) populations.

Being tested
tuberculosis preventive treatment
Keywords
tuberculosis preventive treatment, latent tuberculosis infection, school health services, real-world effectiveness, target trial emulation
Medical subject headings
Latent Tuberculosis, Tuberculosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • tuberculosis preventive treatmentDrug

    3HR 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)

Study groups in NCT07811518
Study groupRoleWhat they receive
TPT GroupActive comparatorInitiation of a short-course TPT regimen (3HR or 3H2P2) within a 14-day grace period following being defined as the date of LTBI diagnosis/eligibility confirmation by school health services.
Receives: Drug: tuberculosis preventive treatment
No-TPT GroupNo interventionNon-initiation of TPT, receiving standard observation and symptom monitoring through school health services.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Up to 4 years post-baseline screening (from T0 through August 31, 2026)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Sep 2026
  2. Study start15 Aug 2022
  3. Primary completion31 Aug 2026
  4. Study completion31 Aug 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Prevention
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
3,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07811518
Sponsor's protocol ID
Tdb2130
Acronym
LIFT-TB
Status last verified
Sep 2026
First submitted
4 Sep 2026
Last updated
10 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • You NN, Zhu LM, Li GL, Martinez L, Lu W, Liu Q, Yang HT. A tuberculosis school outbreak in China, 2018: reaching an often overlooked adolescent population. Epidemiol Infect. 2019 Nov 18;147:e303. doi: 10.1017/S0950268819001882.

    PubMed 31736459

  • Tang J, Xie M, Li C, Huang F, Peng L, Qu Y, Mei J, Liu Z, Liu E, Guo Y, Wang Y. A clustered pulmonary Tuberculosis outbreak at a technical school in Shenzhen, China. Front Pediatr. 2026 May 7;14:1817016. doi: 10.3389/fped.2026.1817016. eCollection 2026.

    PubMed 42181577

  • Sterling TR, Villarino ME, Borisov AS, Shang N, Gordin F, Bliven-Sizemore E, Hackman J, Hamilton CD, Menzies D, Kerrigan A, Weis SE, Weiner M, Wing D, Conde MB, Bozeman L, Horsburgh CR Jr, Chaisson RE; TB Trials Consortium PREVENT TB Study Team. Three months of rifapentine and isoniazid for latent tuberculosis infection. N Engl J Med. 2011 Dec 8;365(23):2155-66. doi: 10.1056/NEJMoa1104875.

    PubMed 22150035

  • Spyridis NP, Spyridis PG, Gelesme A, Sypsa V, Valianatou M, Metsou F, Gourgiotis D, Tsolia MN. The effectiveness of a 9-month regimen of isoniazid alone versus 3- and 4-month regimens of isoniazid plus rifampin for treatment of latent tuberculosis infection in children: results of an 11-year randomized study. Clin Infect Dis. 2007 Sep 15;45(6):715-22. doi: 10.1086/520983. Epub 2007 Aug 6.

    PubMed 17712755

  • Snow KJ, Cruz AT, Seddon JA, Ferrand RA, Chiang SS, Hughes JA, Kampmann B, Graham SM, Dodd PJ, Houben RM, Denholm JT, Sawyer SM, Kranzer K. Adolescent tuberculosis. Lancet Child Adolesc Health. 2020 Jan;4(1):68-79. doi: 10.1016/S2352-4642(19)30337-2. Epub 2019 Nov 18.

    PubMed 31753806

  • Rodriguez-Marquez I, Benjumea-Bedoya D, Restrepo-Gouzy AV, Beltran-Arroyave CP, Marin D, Montes-Zuluaga FN, Alzate-Angel JC, Cadavid-Alvarez LM, Paniagua-Saldarriaga LA, Realpe T, Perea-Torres Y, Arango-Garcia LM, Perez-Doncel N, Arbelaez-Montoya MP, Robledo J. Adherence to treatment for tuberculosis infection in children using a comprehensive care strategy: a prospective cohort study with a historical control group. Lancet Reg Health Am. 2025 Apr 22;46:101094. doi: 10.1016/j.lana.2025.101094. eCollection 2025 Jun.

    PubMed 40329939

  • Pelzer PT, Stuck L, Martinez L, Richards AS, Acuna-Villaorduna C, Aronson NE, Bonnet M, Carvalho AC, Chan PC, Huang LM, Fang CT, Churchyard G, Corral-Londono HD, Datta M, Espinal MA, Fielding K, Fiore-Gartland AJ, Garcia-Basteiro A, Hanekom W, Hatherill M, Hill PC, Huerga H, Jones-Lopez EC, Kritski A, Mandalakas AM, Mangtani P, Martins Netto E, Mayanja H, Mazahir R, Murray M, Rangaka M, Scriba T, Singh J, Singh S, Stein CM, Vekemans J, Verhagen LM, Villalba JA, Wajja A, Watson B, White RG, Cobelens FGJ. Effectiveness of the primary Bacillus Calmette-Guerin vaccine against the risk of Mycobacterium tuberculosis infection and tuberculosis disease: a meta-analysis of individual participant data. Lancet Microbe. 2025 Feb;6(2):100961. doi: 10.1016/j.lanmic.2024.100961. Epub 2024 Dec 19.

    PubMed 39709975

  • Pangprasertkul S, Buawangpong N, Pinyopornpanish K, Jiraporncharoen W, Angkurawaranon C. Treatment completion and safety profile of once-weekly 3HP regimen for tuberculosis preventive treatment in children and adolescents: a systematic review. BMC Infect Dis. 2025 Mar 28;25(1):436. doi: 10.1186/s12879-025-10832-7.

    PubMed 40155893

  • National Tuberculosis Controllers Association; Centers for Disease Control and Prevention (CDC). Guidelines for the investigation of contacts of persons with infectious tuberculosis. Recommendations from the National Tuberculosis Controllers Association and CDC. MMWR Recomm Rep. 2005 Dec 16;54(RR-15):1-47.

    PubMed 16357823

  • Mohle-Boetani JC, Miller B, Halpern M, Trivedi A, Lessler J, Solomon SL, Fenstersheib M. School-based screening for tuberculous infection. A cost-benefit analysis. JAMA. 1995 Aug 23-30;274(8):613-9.

    PubMed 7637141

  • Mandalakas AM, Hesseling AC, Kay A, Du Preez K, Martinez L, Ronge L, DiNardo A, Lange C, Kirchner HL. Tuberculosis prevention in children: a prospective community-based study in South Africa. Eur Respir J. 2021 Apr 22;57(4):2003028. doi: 10.1183/13993003.03028-2020. Print 2021 Apr.

    PubMed 33122339

  • Getahun H, Matteelli A, Chaisson RE, Raviglione M. Latent Mycobacterium tuberculosis infection. N Engl J Med. 2015 May 28;372(22):2127-35. doi: 10.1056/NEJMra1405427. No abstract available.

    PubMed 26017823

  • Gao L, Zhang H, Xin H, Liu J, Pan S, Li X, Guan L, Shen F, Liu Z, Wang D, Guan X, Yan J, Li H, Feng B, Cao X, Chen Y, Cui W, Zhang Z, Ma Y, Chen X, Zhou X, Jin Q; LATENTTB-NSTM study team. Short-course regimens of rifapentine plus isoniazid to treat latent tuberculosis infection in older Chinese patients: a randomised controlled study. Eur Respir J. 2018 Dec 20;52(6):1801470. doi: 10.1183/13993003.01470-2018. Print 2018 Dec.

    PubMed 30361241

  • Gao L, Lu W, Bai L, Wang X, Xu J, Catanzaro A, Cardenas V, Li X, Yang Y, Du J, Sui H, Xia Y, Li M, Feng B, Li Z, Xin H, Zhao R, Liu J, Pan S, Shen F, He J, Yang S, Si H, Wang Y, Xu Z, Tan Y, Chen T, Xu W, Peng H, Wang Z, Zhu T, Zhou F, Liu H, Zhao Y, Cheng S, Jin Q; LATENTTB-NSTM study team. Latent tuberculosis infection in rural China: baseline results of a population-based, multicentre, prospective cohort study. Lancet Infect Dis. 2015 Mar;15(3):310-9. doi: 10.1016/S1473-3099(14)71085-0. Epub 2015 Feb 11.

    PubMed 25681063

  • Benjumea-Bedoya D, Beltran-Arroyave C, Restrepo Gouzy A, Barrera LF, Cadavid LM, Velez-Parra G, Molinares B, Marin D, Montes F, Pulido H, Suarez M, Robledo J, Arbelaez-Montoya MP. The effectiveness of preventive tuberculosis treatment in children. BMC Infect Dis. 2026 Feb 5;26(1):511. doi: 10.1186/s12879-026-12726-8.

    PubMed 41645075

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing tuberculosis preventive treatment in people with Latent Tuberculosis Infection (LTBI) and Tuberculosis (TB), run by Affiliated Hospital of Nantong University at 2 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Gang Qin, MD, PhD (086-189-1228-8106, tonygqin@ntu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incident active tuberculosis (time frame: Up to 4 years post-baseline screening (from T0 through August 31, 2026)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07811518, which also lists 16 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026.

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