What is this study trying to find out about tuberculosis?

This study aims to find out how common tuberculosis infection is among students who have been in close contact with active tuberculosis patients at school. It also looks at factors that increase infection risk and evaluates the cost-effectiveness of screening methods. The research is sponsored by Huashan Hospital to better understand TB infection in school settings.

Who may be eligible for this tuberculosis clinical trial?

Participants should be 13 years or older and currently students in junior middle school, high school, or university. They must have had close contact with a school active tuberculosis case and be willing to participate and provide consent. The study excludes those with active tuberculosis or those who have completed full TB treatment. Please review eligibility criteria for more details.

Is there any cost to participate in this tuberculosis clinical trial?

Study-related care, including the QuantiFERON-TB Gold test and all trial visits, is provided at no cost. However, personal travel expenses and other related costs may vary and are not guaranteed to be covered. Participants should plan accordingly for any travel or accommodation expenses.

Actively Recruiting

Age: 13Years +

All Genders

ID06033807

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

Led by Huashan Hospital · Updated on 2025-04-01

31440

Participants Needed

Research Sites

17 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are studying the rate of Mycobacterium tuberculosis (MTB) infection among students who have been in close contact with active tuberculosis (ATB) patients at school. The study also aims to identify risk factors related to tuberculosis infection and evaluate the health economics of the screening strategy. This observational study is sponsored by Huashan Hospital and focuses on school contacts of ATB patients aged 13 years and older. Participants will undergo the QuantiFERON-TB Gold (QFT) test to determine if they have been infected with MTB. Those who test positive will have further assessments including sputum Xpert MTB/RIF testing, physical examination, chest CT scan, and if necessary, sputum culture to differentiate latent TB infection from active tuberculosis. For participants over 15 years old with a positive QFT result, a chest X-ray scan may also be performed. During the study, participants will provide baseline information including age, sex, vaccination history, contact patterns, and medical history through checklists. Researchers will monitor the prevalence of tuberculosis infection at baseline and collect other relevant data. The study is observational, meaning no treatment is provided, and participants will be followed to understand the infection status and related factors. The total study duration extends until the end of 2025.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 13Years +

All Genders

Eligibility Criteria

You may qualify if you...

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)
Willing to participate in the trial and provide informed consent (with guardian consent if under 18 years old)

You will not qualify if you...

Current clinical or sputum culture confirmed active tuberculosis
Completed a full course of treatment for active or latent tuberculosis infection

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - Approximately 1 to 2 weeks

Participants undergo testing with the QuantiFERON-TB Gold (QFT) test to determine TB infection status. Those with positive results will have further assessments including sputum tests, physical examination, and chest imaging to distinguish latent TB infection from active TB.

1 to 2 visits depending on test results

Long-term Monitoring

Duration - Up to several months until study completion

Participants are observed after diagnostic evaluation to monitor their health status and infection outcomes.

Visits as scheduled during follow-up period

Trial Site Locations

Total: 44 locations

Xinpu New Area Center of Disease Control

Zunyi, Guiyang, China

Actively Recruiting

Dafang Center for Disease Control and Prevention

Bijie, Guizhou, China, 551600

Actively Recruiting

Qixingguan Center for Disease Control and Prevention

Bijie, Guizhou, China, 551700

Actively Recruiting

Nayong Center for Disease Control and Prevention

Bijie, Guizhou, China, 553307

Actively Recruiting

Hezhang Center for Disease Control

Bijie, Guizhou, China

Actively Recruiting

Jinsha Center for Disease Control

Bijie, Guizhou, China

Actively Recruiting

Qianxi Center of Disease Control

Bijie, Guizhou, China

Actively Recruiting

Weining Center of Disease Control

Bijie, Guizhou, China

Actively Recruiting

Zhijin Center of Disease Control

Bijie, Guizhou, China

Actively Recruiting

Liping Center for Disease Control and Prevention

Linping, Guizhou, China, 557300

Actively Recruiting

Liuzhi Special District Center of Disease Control

Liupanshui, Guizhou, China

Actively Recruiting

Panzhou Center of Disease Control

Liupanshui, Guizhou, China

Actively Recruiting

Shuicheng District Center of Disease Control

Liupanshui, Guizhou, China

Actively Recruiting

Cengong Center of Disease Control