TuberculosisNCT06033807
Active Screening of Latent Tuberculosis Infection in School Contacts of Active Tuberculosis Patients
An observational study of Tuberculosis and Latent Tuberculosis Infection, run by Huashan Hospital at 44 sites in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 13 years and older
- Conditions the study is for
- Tuberculosis, Latent Tuberculosis Infection
- What is being tested?
- QuantiFERON-TB Gold (QFT) test
- How many people
- 31,440 participants
- Where
- 44 sitesChina
- Study dates
- 1 Sep 2023to 31 Dec 2025
- How long will I take part?
- 1 Month
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Students in junior middle schools, high schools and universities from Guizhou Province, China
Who may be able to join
- 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.
Who cannot join
- Current clinical or sputum culture confirmed active tuberculosis
- Have completed a full course of treatment for ATB or LTBI
Trial locations and contacts
44 sites in 1 country. Contact the study team or a site near you to ask about taking part.
44 sites in 1 country
China44 sites, 44 recruiting
- Recruiting
Dafang Center for Disease Control and Prevention
Bijie, Guizhou, 551600
Daochun Wan, 15284642890
- Recruiting
Qixingguan Center for Disease Control and Prevention
Bijie, Guizhou, 551700
Chenglin Wang, 13595758657
- Recruiting
Nayong Center for Disease Control and Prevention
Bijie, Guizhou, 553307
Quan Li, 13984788462
- Recruiting
Hezhang Center for Disease Control
Bijie, Guizhou
Yan An, 15902582894
- Recruiting
Jinsha Center for Disease Control
Bijie, Guizhou
Xia Dai, 15085764366
- Recruiting
Qianxi Center of Disease Control
Bijie, Guizhou
Tingting Gong, 15085748336
- Recruiting
Weining Center of Disease Control
Bijie, Guizhou
Liangqun Cai, 13984735596
- Recruiting
Zhijin Center of Disease Control
Bijie, Guizhou
Yan Cao, 18212588909
- Recruiting
Dalian Public Health Clinical Center
Dalian, Liaoning
Xu Cao, MD, 18018918131
- Recruiting
Liping Center for Disease Control and Prevention
Linping, Guizhou, 557300
Zhibo Xu, 18984510861
- Recruiting
Liuzhi Special District Center of Disease Control
Liupanshui, Guizhou
Li Du, 15885488776
- Recruiting
Panzhou Center of Disease Control
Liupanshui, Guizhou
Yao Ren, 13678587905
- Recruiting
Shuicheng District Center of Disease Control
Liupanshui, Guizhou
Pinjun Deng, 18685890688
- Recruiting
Cengong Center of Disease Control
Qiandongnan Miao and Dong Autonomous Prefecture, Guizhou
Liyan Cao, 18985809522
- Recruiting
Congjiang Ceter of Disease Control
Qiandongnan Miao and Dong Autonomous Prefecture, Guizhou
Lanzhen Li, 18084541870
- Recruiting
Danzhai Center of Disease Control
Qiandongnan Miao and Dong Autonomous Prefecture, Guizhou
Zhixin Mao, 15008552512
- Recruiting
Huangping Center of Disease Control
Qiandongnan Miao and Dong Autonomous Prefecture, Guizhou
Li Deng, 15186771812
- Recruiting
Jianhe Center of Disease Control
Qiandongnan Miao and Dong Autonomous Prefecture, Guizhou
Weiqiong Zeng, 18798085536
- Recruiting
Jinping Center of Disease Control
Qiandongnan Miao and Dong Autonomous Prefecture, Guizhou
Yunhua Liu, 13765541098
- Recruiting
Kaili Center of Disease Control
Qiandongnan Miao and Dong Autonomous Prefecture, Guizhou
Hongzhi Luo, 18908553118
- Recruiting
Leishan Center of Disease Control
Qiandongnan Miao and Dong Autonomous Prefecture, Guizhou
Xingqin Hou, 15870282630
- Recruiting
Majiang Center of Disease Control
Qiandongnan Miao and Dong Autonomous Prefecture, Guizhou
Jianghong Li, 13885553585
- Recruiting
Rongjiang Center of Disease Control
Qiandongnan Miao and Dong Autonomous Prefecture, Guizhou
Faxiang Ding, 18230706792
- Recruiting
Sansui Center of Disease Control
Qiandongnan Miao and Dong Autonomous Prefecture, Guizhou
Yuxian Ma, 15808553232
- Recruiting
Shibing Center of Disease Control
Qiandongnan Miao and Dong Autonomous Prefecture, Guizhou
Yuzhao Li, 15085965105
- Recruiting
Taijiang Center of Disease Control
Qiandongnan Miao and Dong Autonomous Prefecture, Guizhou
Wenzhi Jiang, 15985569758
- Recruiting
Tianzhu Center of Disease Control
Qiandongnan Miao and Dong Autonomous Prefecture, Guizhou
Zhijun Gong, 15885837870
- Recruiting
Zhenyuan Center of Disease Control
Qiandongnan Miao and Dong Autonomous Prefecture, Guizhou
Xiaorong Huang, 15772565159
- Recruiting
Qingzhen Center for Disease Control and Prevention
Qingzhen, Guizhou, 551400
Yan Guo, 15885026866
- Recruiting
Xinpu New Area Center of Disease Control
Zunyi, Guiyang
Youqian Chen, 15870102934
- Recruiting
Bozhou District Center of Disease Control
Zunyi, Guizhou
Xuanbi Cheng, 15085038024
- Recruiting
Chishui Center of Disease Control
Zunyi, Guizhou
Kun Chen, 18089633633
- Recruiting
Daozhen Center of Disease Control
Zunyi, Guizhou
Ruiai Dai, 13312352918
- Recruiting
Fenggang Center of Disease Control
Zunyi, Guizhou
Yuting Zeng, 18108526288
- Recruiting
Honghuagang District Center of Disease Control
Zunyi, Guizhou
Wenjun Chen, 18586309099
- Recruiting
Huichuan District Center of Disease Control
Zunyi, Guizhou
Jing Chen, 15285210676
- Recruiting
Meitan Center of Disease Control
Zunyi, Guizhou
Yao Gu, 18089643262
- Recruiting
Renhuai Center of Disease Control
Zunyi, Guizhou
Yongming Cai, 15329726369
- Recruiting
Suiyang Center of Disease Control
Zunyi, Guizhou
Guolu Li, 18785234637
- Recruiting
Tongzi Center of Disease Control
Zunyi, Guizhou
Lianlian Bi, 13985668150
- Recruiting
Wuchuan Center of Disease Control
Zunyi, Guizhou
Lilan He, 15085549517
- Recruiting
Xishui Center of Disease Control
Zunyi, Guizhou
Jie Chen, 15348634987
- Recruiting
Yuqing Center of Disease Control
Zunyi, Guizhou
Ya Zeng, 18786337967
- Recruiting
Zhengan Center of Disease Control
Zunyi, Guizhou
Zheng Cao, 13310423132
About this study
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
- Conditions
- Tuberculosis, Latent Tuberculosis Infection
- Being tested
- QuantiFERON-TB Gold (QFT) test
- Keywords
- latent tuberculosis, active screening
- Medical subject headings
- Tuberculosis, Latent Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuantiFERON-TB Gold (QFT) testDiagnostic test
Also called Chest CT Scan, Chest X-ray Scan, Sputum Culture, Sputum Xpert MTB/RIF
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.
| Study group | Role | What they receive |
|---|---|---|
| Contacts | School contacts of ATB patients Receives: Diagnostic Test: QuantiFERON-TB Gold (QFT) test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: baseline
Secondary outcomes (5)
Age
Age as possible risk factor of tuberculosis infection
Measured: baseline
Sex
Sex as possible risk factor of tuberculosis infection.
Measured: baseline
Vaccination history checklist
Bacillus Calmette-Guérin (BCG) vaccination history as possible risk factor of tuberculosis infection.
Measured: baseline
Patterns of contacting checklist
Duration, size of space of exposure to active tuberculosis-infected patient; as possible risk factor of tuberculosis infection.
Measured: 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.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2023
- Study start1 Sep 2023
- Primary completion1 Sep 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TuberculosisStudies of the same condition, open and under way.
- More trials run by Huashan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 31,440 participants (estimated)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Huashan Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Guizhou Center for Disease Control and Prevention
- Responsible party
- Principal investigator, Wen-hong Zhang, Huashan Hospital
- Investigators
- Wenhong Zhang, PhD, Principal investigator, Huashan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06033807
- Sponsor's protocol ID
- TB-Youth Screening
- Status last verified
- Mar 2025
- First submitted
- 29 Aug 2023
- Last updated
- 1 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This research targets adolescent students in school. We decide not to share IPD from the ethical perspective.
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Active Screening of Latent Tuberculosis Infection in School Contacts of Active Tuberculosis Patients
- ClinicalTrials.gov ID
- NCT06033807
- Acronym / sponsor ID
- TB-Youth Screening
- Conditions
- Tuberculosis, Latent Tuberculosis Infection
- Keywords
- latent tuberculosis, active screening
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 31,440 participants (estimated)
- Lead sponsor
- Huashan HospitalUniversity, hospital or other
- Collaborators
- Guizhou Center for Disease Control and Prevention
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 1 Sep 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 13 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Month
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Contacts | – | Diagnostic Test: QuantiFERON-TB Gold (QFT) testSchool contacts of ATB patients |
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Students in junior middle schools, high schools and universities from Guizhou Province, China
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- Current clinical or sputum culture confirmed active tuberculosis
- Have completed a full course of treatment for ATB or LTBI
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuantiFERON-TB Gold (QFT) testAlso: Chest CT Scan, Chest X-ray Scan, Sputum Culture, Sputum Xpert MTB/RIFParticipants 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. | Diagnostic test | Contacts |
Primary outcome
The prevalence of tuberculosis (TB) infection in school contacts
Time frame: 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).
5 secondary outcomes
Age
Time frame: baseline
Sex
Time frame: baseline
Vaccination history checklist
Time frame: baseline
Patterns of contacting checklist
Time frame: baseline
Co-morbidities / medical history checklist
Time frame: baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2025.
- Individual participant dataSharing planned: No. This research targets adolescent students in school. We decide not to share IPD from the ethical perspective.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Wenhong Zhang, PhD principal investigator
Huashan Hospital
44 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tuberculosis and Latent Tuberculosis Infection, run by Huashan Hospital at 44 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 44 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Qiaoling Ruan, PhD (13661856002, ruan_qiao_ling@fudan.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The prevalence of tuberculosis (TB) infection in school contacts (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2025.