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

Recruiting

• Conditions: Tuberculosis; Latent Tuberculosis Infection

• Registration Number: NCT06033807
• Lead Sponsor: Huashan Hospital

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-08-29
• Study Start: 2023-09-01
• Study First Submitted QC: 2023-09-11
• Study First Posted: 2023-09-13
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-26
• Last Update Posted: 2025-04-01
• Primary Completion: 2025-09-01
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 31440

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The prevalence of tuberculosis (TB) infection in school contacts	baseline	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).

Secondary Outcome Measures

Name	Time	Method
Vaccination history checklist	baseline	Bacillus Calmette-Guérin (BCG) vaccination history as possible risk factor of tuberculosis infection.
Co-morbidities / medical history checklist	baseline	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.
Age	baseline	Age as possible risk factor of tuberculosis infection
Sex	baseline	Sex as possible risk factor of tuberculosis infection.
Patterns of contacting checklist	baseline	Duration, size of space of exposure to active tuberculosis-infected patient; as possible risk factor of tuberculosis infection.

Trial Locations

Locations (44)

Xinpu New Area Center of Disease Control; 🇨🇳 Zunyi, Guiyang, China

Hezhang Center for Disease Control; 🇨🇳 Bijie, Guizhou, China

Jinsha Center for Disease Control; 🇨🇳 Bijie, Guizhou, China

Qianxi Center of Disease Control; 🇨🇳 Bijie, Guizhou, China

Weining Center of Disease Control; 🇨🇳 Bijie, Guizhou, China

Zhijin Center of Disease Control; 🇨🇳 Bijie, Guizhou, China

Liuzhi Special District Center of Disease Control; 🇨🇳 Liupanshui, Guizhou, China

Panzhou Center of Disease Control; 🇨🇳 Liupanshui, Guizhou, China

Shuicheng District Center of Disease Control; 🇨🇳 Liupanshui, Guizhou, China

Cengong Center of Disease Control; 🇨🇳 Qiandongnan Miao and Dong Autonomous Prefecture, Guizhou, China

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