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

Tuberculosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06033807
• Other study ID #: TB-Youth Screening
• Status: Recruiting
• Start date: September 1, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: September 2023
• Source: Huashan Hospital
• Contact: Qiaoling Ruan, PhD
• Phone: 13661856002
• Email: ruan_qiao_ling[@]fudan.edu.cn
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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 tuberculosis (TB) infection

• health economic evaluation of screening strategy

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 31440
• Est. completion date: December 31, 2025
• Est. primary completion date: September 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Infections
• Latent Tuberculosis
• Latent Tuberculosis Infection
• Tuberculosis

Intervention

Diagnostic Test:
• QuantiFERON-TB Gold (QFT) 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.

Locations

Country	Name	City	State
China	Dafang Center for Disease Control and Prevention	Bijie	Guizhou
China	Nayong Center for Disease Control and Prevention	Bijie	Guizhou
China	Qixingguan Center for Disease Control and Prevention	Bijie	Guizhou
China	Liping Center for Disease Control and Prevention	Linping	Guizhou
China	Qingzhen Center for Disease Control and Prevention	Qingzhen	Guizhou

Sponsors (2)

Lead Sponsor	Collaborator
Huashan Hospital	Guizhou Center for Disease Control and Prevention

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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-? detected in at least one test tube (TB1 or TB2).	baseline
Secondary	Age	Age as possible risk factor of tuberculosis infection	baseline
Secondary	Sex	Sex as possible risk factor of tuberculosis infection.	baseline
Secondary	Vaccination history checklist	Bacillus Calmette-Guérin (BCG) vaccination history as possible risk factor of tuberculosis infection.	baseline
Secondary	Patterns of contacting checklist	Duration, size of space of exposure to active tuberculosis-infected patient; as possible risk factor of tuberculosis infection.	baseline
Secondary	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.	baseline