Active Screening of Latent Tuberculosis Infection in School Contacts of Active Tuberculosis Patients

The goal of this observational study is to investigate the proportion of Mycobacterium tuberculosis (MTB) infection in school contacts of active tuberculosis (ATB) patients. The main questions it aims to answer are:

• the proportion of MTB infection among school contacts of ATB patients
• risk factors related to tuberculosis (TB) infection
• health economic evaluation of screening strategy

Study Overview

• Status: Recruiting
• Conditions: Tuberculosis; Latent Tuberculosis Infection
• Intervention / Treatment: Diagnostic test: QuantiFERON-TB Gold (QFT) test

• Study Type: Observational
• Enrollment (Estimated): 31440

Contacts and Locations

• Study Contact: Name: Qiaoling Ruan, PhD; Phone Number: 13661856002; Email: ruan_qiao_ling@fudan.edu.cn
• Study Contact Backup: Name: Jinlan Li, MPH; Phone Number: 13985045080; Email: 740820442@qq.com

Study Locations

• China
  • Guiyang
    • Zunyi, Guiyang, China
      • Recruiting
      • Xinpu New Area Center of Disease Control
      • Contact: Youqian Chen; Phone Number: 15870102934
  • Guizhou
    • Bijie, Guizhou, China, 551600
      • Recruiting
      • Dafang Center for Disease Control and Prevention
      • Contact: Daochun Wan; Phone Number: 15284642890
    • Bijie, Guizhou, China, 551700
      • Recruiting
      • Qixingguan Center for Disease Control and Prevention
      • Contact: Chenglin Wang; Phone Number: 13595758657
    • Bijie, Guizhou, China, 553307
      • Recruiting
      • Nayong Center for Disease Control and Prevention
      • Contact: Quan Li; Phone Number: 13984788462
    • Bijie, Guizhou, China
      • Recruiting
      • Hezhang Center for Disease Control
      • Contact: Yan An; Phone Number: 15902582894
    • Bijie, Guizhou, China
      • Recruiting
      • Jinsha Center for Disease Control
      • Contact: Xia Dai; Phone Number: 15085764366
    • Bijie, Guizhou, China
      • Recruiting
      • Qianxi Center of Disease Control
      • Contact: Tingting Gong; Phone Number: 15085748336
    • Bijie, Guizhou, China
      • Recruiting
      • Weining Center of Disease Control
      • Contact: Liangqun Cai; Phone Number: 13984735596
    • Bijie, Guizhou, China
      • Recruiting
      • Zhijin Center of Disease Control
      • Contact: Yan Cao; Phone Number: 18212588909
    • Linping, Guizhou, China, 557300
      • Recruiting
      • Liping Center for Disease Control and Prevention
      • Contact: Zhibo Xu; Phone Number: 18984510861
    • Liupanshui, Guizhou, China
      • Recruiting
      • Liuzhi Special District Center of Disease Control
      • Contact: Li Du; Phone Number: 15885488776
    • Liupanshui, Guizhou, China
      • Recruiting
      • Panzhou Center of Disease Control
      • Contact: Yao Ren; Phone Number: 13678587905
    • Liupanshui, Guizhou, China
      • Recruiting
      • Shuicheng District Center of Disease Control
      • Contact: Pinjun Deng; Phone Number: 18685890688
    • Qiandongnan Miao and Dong Autonomous Prefecture, Guizhou, China
      • Recruiting
      • Cengong Center of Disease Control
      • Contact: Liyan Cao; Phone Number: 18985809522
    • Qiandongnan Miao and Dong Autonomous Prefecture, Guizhou, China
      • Recruiting
      • Congjiang Ceter of Disease Control
      • Contact: Lanzhen Li; Phone Number: 18084541870
    • Qiandongnan Miao and Dong Autonomous Prefecture, Guizhou, China
      • Recruiting
      • Danzhai Center of Disease Control
      • Contact: Zhixin Mao; Phone Number: 15008552512
    • Qiandongnan Miao and Dong Autonomous Prefecture, Guizhou, China
      • Recruiting
      • Huangping Center of Disease Control
      • Contact: Li Deng; Phone Number: 15186771812
    • Qiandongnan Miao and Dong Autonomous Prefecture, Guizhou, China
      • Recruiting
      • Jianhe Center of Disease Control
      • Contact: Weiqiong Zeng; Phone Number: 18798085536
    • Qiandongnan Miao and Dong Autonomous Prefecture, Guizhou, China
      • Recruiting
      • Jinping Center of Disease Control
      • Contact: Yunhua Liu; Phone Number: 13765541098
    • Qiandongnan Miao and Dong Autonomous Prefecture, Guizhou, China
      • Recruiting
      • Kaili Center of Disease Control
      • Contact: Hongzhi Luo; Phone Number: 18908553118
    • Qiandongnan Miao and Dong Autonomous Prefecture, Guizhou, China
      • Recruiting
      • Leishan Center of Disease Control
      • Contact: Xingqin Hou; Phone Number: 15870282630
    • Qiandongnan Miao and Dong Autonomous Prefecture, Guizhou, China
      • Recruiting
      • Majiang Center of Disease Control
      • Contact: Jianghong Li; Phone Number: 13885553585
    • Qiandongnan Miao and Dong Autonomous Prefecture, Guizhou, China
      • Recruiting
      • Rongjiang Center of Disease Control
      • Contact: Faxiang Ding; Phone Number: 18230706792
    • Qiandongnan Miao and Dong Autonomous Prefecture, Guizhou, China
      • Recruiting
      • Sansui Center of Disease Control
      • Contact: Yuxian Ma; Phone Number: 15808553232
    • Qiandongnan Miao and Dong Autonomous Prefecture, Guizhou, China
      • Recruiting
      • Shibing Center of Disease Control
      • Contact: Yuzhao Li; Phone Number: 15085965105
    • Qiandongnan Miao and Dong Autonomous Prefecture, Guizhou, China
      • Recruiting
      • Taijiang Center of Disease Control
      • Contact: Wenzhi Jiang; Phone Number: 15985569758
    • Qiandongnan Miao and Dong Autonomous Prefecture, Guizhou, China
      • Recruiting
      • Tianzhu Center of Disease Control
      • Contact: Zhijun Gong; Phone Number: 15885837870
    • Qiandongnan Miao and Dong Autonomous Prefecture, Guizhou, China
      • Recruiting
      • Zhenyuan Center of Disease Control
      • Contact: Xiaorong Huang; Phone Number: 15772565159
    • Qingzhen, Guizhou, China, 551400
      • Recruiting
      • Qingzhen Center for Disease Control and Prevention
      • Contact: Yan Guo; Phone Number: 15885026866
    • Zunyi, Guizhou, China
      • Recruiting
      • Bozhou District Center of Disease Control
      • Contact: Xuanbi Cheng; Phone Number: 15085038024
    • Zunyi, Guizhou, China
      • Recruiting
      • Chishui Center of Disease Control
      • Contact: Kun Chen; Phone Number: 18089633633
    • Zunyi, Guizhou, China
      • Recruiting
      • Daozhen Center of Disease Control
      • Contact: Ruiai Dai; Phone Number: 13312352918
    • Zunyi, Guizhou, China
      • Recruiting
      • Fenggang Center of Disease Control
      • Contact: Yuting Zeng; Phone Number: 18108526288
    • Zunyi, Guizhou, China
      • Recruiting
      • Honghuagang District Center of Disease Control
      • Contact: Wenjun Chen; Phone Number: 18586309099
    • Zunyi, Guizhou, China
      • Recruiting
      • Huichuan District Center of Disease Control
      • Contact: Jing Chen; Phone Number: 15285210676
    • Zunyi, Guizhou, China
      • Recruiting
      • Meitan Center of Disease Control
      • Contact: Yao Gu; Phone Number: 18089643262
    • Zunyi, Guizhou, China
      • Recruiting
      • Renhuai Center of Disease Control
      • Contact: Yongming Cai; Phone Number: 15329726369
    • Zunyi, Guizhou, China
      • Recruiting
      • Suiyang Center of Disease Control
      • Contact: Guolu Li; Phone Number: 18785234637
    • Zunyi, Guizhou, China
      • Recruiting
      • Tongzi Center of Disease Control
      • Contact: Lianlian Bi; Phone Number: 13985668150
    • Zunyi, Guizhou, China
      • Recruiting
      • Wuchuan Center of Disease Control
      • Contact: Lilan He; Phone Number: 15085549517
    • Zunyi, Guizhou, China
      • Recruiting
      • Xishui Center of Disease Control
      • Contact: Jie Chen; Phone Number: 15348634987
    • Zunyi, Guizhou, China
      • Recruiting
      • Yuqing Center of Disease Control
      • Contact: Ya Zeng; Phone Number: 18786337967
    • Zunyi, Guizhou, China
      • Recruiting
      • Zhengan Center of Disease Control
      • Contact: Zheng Cao; Phone Number: 13310423132
  • Liaoning
    • Dalian, Liaoning, China
      • Recruiting
      • Dalian Public Health Clinical Center
      • Contact: Xu Cao, MD; Phone Number: 18018918131

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Students in junior middle schools, high schools and universities from Guizhou Province, China

Description

Inclusion Criteria:

• 13 years old or above;
• Students in junior middle school, high school and university;
• Close contact of school active tuberculosis case (e.g. in the same classroom, in the same dormitory);
• Himself/herself (together with his/her guardian for age under 18 years old) willing to participate in trial and sign informed consent.

Exclusion Criteria:

• Current clinical or sputum culture confirmed active tuberculosis
• Have completed a full course of treatment for ATB or LTBI

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Contacts; School contacts of ATB patients

Diagnostic test: QuantiFERON-TB Gold (QFT) test; Participants will be tested by QuantiFERON-TB Gold (QFT) test to see if they have ever infected by MTB. Those with positive results will proceed to sputum Xpert MTB/RIF, physical examination and chest CT scan, as well as sputum culture if necessary to distinguish latent TB infection (LTBI) from ATB. X-ray scan is conditional on age above 15 years with a positive QuantiFERON-TB Gold (QFT) test result.; Other Names: Chest CT Scan; Chest X-ray Scan; Sputum Culture; Sputum Xpert MTB/RIF

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The prevalence of tuberculosis (TB) infection in school contacts	The prevalence of TB infection is defined as the number of participants with positive results in QuantiFERON-TB Gold (QFT) test in study population. Positive result in QFT test indicates higher response than the cut-off value of 0.35 IU / ml of INF-γ detected in at least one test tube (TB1 or TB2).	baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Age	Age as possible risk factor of tuberculosis infection	baseline
Sex	Sex as possible risk factor of tuberculosis infection.	baseline
Vaccination history checklist	Bacillus Calmette-Guérin (BCG) vaccination history as possible risk factor of tuberculosis infection.	baseline
Patterns of contacting checklist	Duration, size of space of exposure to active tuberculosis-infected patient; as possible risk factor of tuberculosis infection.	baseline
Co-morbidities / medical history checklist	Co-morbidities / medical history [cardiovascular disease, bronchial asthma, digestive ulcer, nephritic syndrome, glomerulonephritis, diabetes, hyperthyroidism, systemic lupus erythematosus, ankylosing spondylitis, epilepsy, schizophrenia, depression, HIV infection, glucocorticoid use, biologic agent use, immunosuppressive agent use, or other relevant co-morbidities / medical history]; as possible risk factor of tuberculosis infection.	baseline

Collaborators and Investigators

• Sponsor: Huashan Hospital
• Collaborators: Guizhou Center for Disease Control and Prevention
• Investigators: Principal Investigator: Wenhong Zhang, PHD, Huashan Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2023
• Primary Completion (Estimated): September 1, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: August 29, 2023
• First Submitted That Met QC Criteria: September 11, 2023
• First Posted (Actual): September 13, 2023

Study Record Updates

• Last Update Posted (Actual): April 1, 2025
• Last Update Submitted That Met QC Criteria: March 26, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: latent tuberculosis; active screening
• Additional Relevant MeSH Terms: Latent Infection; Pathologic Processes; Disease Attributes; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Actinomycetales Infections; Mycobacterium Infections; Infections; Communicable Diseases; Tuberculosis; Latent Tuberculosis
• Other Study ID Numbers: TB-Youth Screening

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: This research targets adolescent students in school. We decide not to share IPD from the ethical perspective.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No