Clinical trial NCT06033807: Active Screening of Latent Tuberculosis Infection in School Contacts of Active Tuberculosis Patients
Official title: Active Screening of Latent Tuberculosis Infection in School Contacts of Active Tuberculosis Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Tuberculosis
Latent Tuberculosis Infection
Keywords: latent tuberculosis
active screening
Lead sponsor: Huashan Hospital
Sponsor class: OTHER
Collaborators: name: Guizhou Center for Disease Control and Prevention
First posted: 2023-09-13
Enrollment: 31440
Sex: ALL
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Students in junior middle schools, high schools and universities from Guizhou Province, China

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


Eligibility criteria: 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

Primary outcomes:
measure: The prevalence of tuberculosis (TB) infection in school contacts
timeFrame: baseline
Secondary outcomes:
measure: Age
timeFrame: baseline
measure: Sex
timeFrame: baseline
measure: Vaccination history checklist
timeFrame: baseline
measure: Patterns of contacting checklist
timeFrame: baseline
measure: Co-morbidities / medical history checklist
timeFrame: baseline
Other outcomes:
Locations:
city: Zunyi
country: China
facility: Xinpu New Area Center of Disease Control
state: Guiyang
city: Bijie
country: China
facility: Dafang Center for Disease Control and Prevention
state: Guizhou
city: Bijie
country: China
facility: Qixingguan Center for Disease Control and Prevention
state: Guizhou
city: Bijie
country: China
facility: Nayong Center for Disease Control and Prevention
state: Guizhou
city: Bijie
country: China
facility: Hezhang Center for Disease Control
state: Guizhou
city: Bijie
country: China
facility: Jinsha Center for Disease Control
state: Guizhou
city: Bijie
country: China
facility: Qianxi Center of Disease Control
state: Guizhou
city: Bijie
country: China
facility: Weining Center of Disease Control
state: Guizhou
city: Bijie
country: China
facility: Zhijin Center of Disease Control
state: Guizhou
city: Linping
country: China
facility: Liping Center for Disease Control and Prevention
state: Guizhou
city: Liupanshui
country: China
facility: Liuzhi Special District Center of Disease Control
state: Guizhou
city: Liupanshui
country: China
facility: Panzhou Center of Disease Control
state: Guizhou
city: Liupanshui
country: China
facility: Shuicheng District Center of Disease Control
state: Guizhou
city: Qiandongnan Miao and Dong Autonomous Prefecture
country: China
facility: Cengong Center of Disease Control
state: Guizhou
city: Qiandongnan Miao and Dong Autonomous Prefecture
country: China
facility: Congjiang Ceter of Disease Control
state: Guizhou
city: Qiandongnan Miao and Dong Autonomous Prefecture
country: China
facility: Danzhai Center of Disease Control
state: Guizhou
city: Qiandongnan Miao and Dong Autonomous Prefecture
country: China
facility: Huangping Center of Disease Control
state: Guizhou
city: Qiandongnan Miao and Dong Autonomous Prefecture
country: China
facility: Jianhe Center of Disease Control
state: Guizhou
city: Qiandongnan Miao and Dong Autonomous Prefecture
country: China
facility: Jinping Center of Disease Control
state: Guizhou
city: Qiandongnan Miao and Dong Autonomous Prefecture
country: China
facility: Kaili Center of Disease Control
state: Guizhou
city: Qiandongnan Miao and Dong Autonomous Prefecture
country: China
facility: Leishan Center of Disease Control
state: Guizhou
city: Qiandongnan Miao and Dong Autonomous Prefecture
country: China
facility: Majiang Center of Disease Control
state: Guizhou
city: Qiandongnan Miao and Dong Autonomous Prefecture
country: China
facility: Rongjiang Center of Disease Control
state: Guizhou
city: Qiandongnan Miao and Dong Autonomous Prefecture
country: China
facility: Sansui Center of Disease Control
state: Guizhou
city: Qiandongnan Miao and Dong Autonomous Prefecture
country: China
facility: Shibing Center of Disease Control
state: Guizhou
city: Qiandongnan Miao and Dong Autonomous Prefecture
country: China
facility: Taijiang Center of Disease Control
state: Guizhou
city: Qiandongnan Miao and Dong Autonomous Prefecture
country: China
facility: Tianzhu Center of Disease Control
state: Guizhou
city: Qiandongnan Miao and Dong Autonomous Prefecture
country: China
facility: Zhenyuan Center of Disease Control
state: Guizhou
city: Qingzhen
country: China
facility: Qingzhen Center for Disease Control and Prevention
state: Guizhou
city: Zunyi
country: China
facility: Bozhou District Center of Disease Control
state: Guizhou
city: Zunyi
country: China
facility: Chishui Center of Disease Control
state: Guizhou
city: Zunyi
country: China
facility: Daozhen Center of Disease Control
state: Guizhou
city: Zunyi
country: China
facility: Fenggang Center of Disease Control
state: Guizhou
city: Zunyi
country: China
facility: Honghuagang District Center of Disease Control
state: Guizhou
city: Zunyi
country: China
facility: Huichuan District Center of Disease Control
state: Guizhou
city: Zunyi
country: China
facility: Meitan Center of Disease Control
state: Guizhou
city: Zunyi
country: China
facility: Renhuai Center of Disease Control
state: Guizhou
city: Zunyi
country: China
facility: Suiyang Center of Disease Control
state: Guizhou
city: Zunyi
country: China
facility: Tongzi Center of Disease Control
state: Guizhou
city: Zunyi
country: China
facility: Wuchuan Center of Disease Control
state: Guizhou
city: Zunyi
country: China
facility: Xishui Center of Disease Control
state: Guizhou
city: Zunyi
country: China
facility: Yuqing Center of Disease Control
state: Guizhou
city: Zunyi
country: China
facility: Zhengan Center of Disease Control
state: Guizhou
city: Dalian
country: China
facility: Dalian Public Health Clinical Center
state: Liaoning
Study officials:
affiliation: Huashan Hospital
name: Wenhong Zhang, PhD
role: PRINCIPAL_INVESTIGATOR
References: