Latent Infection Freshmen Tracking for Tuberculosis

NCT07811518 | Recruiting Phase 4 DMC

• 1 other identifier: Tdb2130
• Study Type: interventional
• Target: 3,000
• Locations: 1 country
• Sites: 2

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.

Conditions

Latent Tuberculosis Infection (LTBI); Tuberculosis (TB)

Keywords

tuberculosis preventive treatment; latent tuberculosis infection; school health services; real-world effectiveness; target trial emulation

Outcome Measures

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.

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

Study Arms (2)

TPT Group

ACTIVE COMPARATOR

Initiation 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.

Drug: tuberculosis preventive treatment

No-TPT Group

NO INTERVENTION

Non-initiation of TPT, receiving standard observation and symptom monitoring through school health services.

Interventions

tuberculosis preventive treatment DRUG

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)

TPT Group

Eligibility Criteria

• Age: 14 Years - 24 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• Affiliated Hospital of Nantong University: lead
• Meishan Municipal Center for Disease Prevention and Control: collaborator

Study Sites (2)

Affiliated Hospital of Nantong University

Nantong, Jiangsu, 226001, China

RECRUITING

Meishan Municipal Center for Disease Prevention and Control

Meishan, Sichuan, 620010, China

RECRUITING

Related Publications (16)

• 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.

  PMID: 31736459 BACKGROUND

• 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.

  PMID: 42181577 BACKGROUND

• 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.

  PMID: 22150035 BACKGROUND

• 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.

  PMID: 17712755 BACKGROUND

• 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.

  PMID: 31753806 BACKGROUND

• 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.

  PMID: 40329939 BACKGROUND

• 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.

  PMID: 39709975 BACKGROUND

• 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.

  PMID: 40155893 BACKGROUND

• 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.

  PMID: 16357823 BACKGROUND

• 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.

  PMID: 7637141 BACKGROUND

• 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.

  PMID: 33122339 BACKGROUND

• 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.

  PMID: 26017823 BACKGROUND

• 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.

  PMID: 30361241 BACKGROUND

• 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.

  PMID: 25681063 BACKGROUND

• 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.

  PMID: 41645075 BACKGROUND

• Bao H, Liu K, Wu Z, Wang X, Chai C, He T, Wang W, Wang F, Peng Y, Chen B, Jiang J. Tuberculosis outbreaks among students in mainland China: a systematic review and meta-analysis. BMC Infect Dis. 2019 Nov 14;19(1):972. doi: 10.1186/s12879-019-4573-3.

  PMID: 31727001 BACKGROUND

MeSH Terms

Conditions

Latent Tuberculosis; Tuberculosis

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Latent Infection

Central Study Contacts

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 4, 2026
• First Posted: September 10, 2026
• Study Start: August 15, 2022
• Primary Completion: August 31, 2026
• Study Completion (Estimated): August 31, 2029
• Last Updated: September 10, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)