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NCT Number: NCT06033807

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

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

Recruiting

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Key information

Conditions

Tuberculosis Actinomycetales Infections Bacterial Infections Bacterial Infections and Mycoses Gram-Positive Bacterial Infections Infections Latent Infection Latent Tuberculosis Latent Tuberculosis Infection Mycobacterium Infections

Age range

13 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Xinpu New Area Center of Disease Control, Zunyi, Guiyang, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

QuantiFERON-TB Gold (QFT) test

Diagnostic 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.

Other names: Chest CT Scan, Chest X-ray Scan, Sputum Culture, Sputum Xpert MTB/RIF

Primary outcomes

  1. 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).

Secondary outcomes

  1. Age

    Time frame: baseline

    Age as possible risk factor of tuberculosis infection

  2. Sex

    Time frame: baseline

    Sex as possible risk factor of tuberculosis infection.

  3. Vaccination history checklist

    Time frame: baseline

    Bacillus Calmette-Guérin (BCG) vaccination history as possible risk factor of tuberculosis infection.

  4. Patterns of contacting checklist

    Time frame: baseline

    Duration, size of space of exposure to active tuberculosis-infected patient; as possible risk factor of tuberculosis infection.

  5. Co-morbidities / medical history checklist

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Jinlan Li, MPH

CONTACT

[email protected]

13985045080

Qiaoling Ruan, PhD

CONTACT

[email protected]

13661856002

Sponsors and collaborators

Lead sponsor

Huashan Hospital

Other

Collaborators

  • Guizhou Center for Disease Control and Prevention

Registry information

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Sep 13, 2023
Registry last updated
Apr 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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