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

Trial Health

Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date

Enrollment

31,440

participants targeted

Target at P75+ for all trials

Timeline

Completed

Started Sep 2023

Typical duration for all trials

Geographic Reach

1 country

44 active sites

Status

recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

2.3 years study duration

First Submitted

Initial submission to the registry

August 29, 2023

Completed

3 days until next milestone

Study Start

First participant enrolled

September 1, 2023

Completed

12 days until next milestone

First Posted

Study publicly available on registry

September 13, 2023

Completed

2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2025

Completed

4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed

Last Updated

April 1, 2025

Status Verified

March 1, 2025

Enrollment Period

2 years

First QC Date

August 29, 2023

Last Update Submit

March 26, 2025

Conditions

Tuberculosis Latent Tuberculosis Infection

Keywords

latent tuberculosisactive screening

Outcome Measures

Primary Outcomes (1)

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 Outcomes (5)

Age
baseline
Sex
baseline
Vaccination history checklist
baseline
Patterns of contacting checklist
baseline
Co-morbidities / medical history checklist
baseline

Study Arms (1)

Contacts

School contacts of ATB patients

Diagnostic Test: QuantiFERON-TB Gold (QFT) test

Interventions

QuantiFERON-TB Gold (QFT) testDIAGNOSTIC_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.

Also known as: Chest CT Scan, Chest X-ray Scan, Sputum Culture, Sputum Xpert MTB/RIF

Contacts

Eligibility Criteria

Age13 Years+

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

Sampling MethodProbability Sample

Study Population

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

You may qualify if:

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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Huashan Hospitallead
Guizhou Center for Disease Control and Preventioncollaborator

Study Sites (44)

Xinpu New Area Center of Disease Control

Zunyi, Guiyang, China

RECRUITING

Dafang Center for Disease Control and Prevention

Bijie, Guizhou, 551600, China

RECRUITING

Qixingguan Center for Disease Control and Prevention

Bijie, Guizhou, 551700, China

RECRUITING

Nayong Center for Disease Control and Prevention

Bijie, Guizhou, 553307, China

RECRUITING

Hezhang Center for Disease Control

Bijie, Guizhou, China

RECRUITING

Jinsha Center for Disease Control

Bijie, Guizhou, China

RECRUITING

Qianxi Center of Disease Control

Bijie, Guizhou, China

RECRUITING

Weining Center of Disease Control

Bijie, Guizhou, China

RECRUITING

Zhijin Center of Disease Control

Bijie, Guizhou, China

RECRUITING

Liping Center for Disease Control and Prevention

Linping, Guizhou, 557300, China

RECRUITING

Liuzhi Special District Center of Disease Control

Liupanshui, Guizhou, China

RECRUITING

Panzhou Center of Disease Control

Liupanshui, Guizhou, China

RECRUITING

Shuicheng District Center of Disease Control

Liupanshui, Guizhou, China

RECRUITING

Cengong Center of Disease Control