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Recruiting NCT06033807

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

Observational Tuberculosis Latent Tuberculosis Infection

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: QuantiFERON-TB Gold (QFT) test.
Who it may be relevant to
Registry conditions: Tuberculosis, Latent Tuberculosis Infection. Basic parameters: from 13 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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

Interventions

  • 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.

Primary outcome measures

  • The prevalence of tuberculosis (TB) infection in school contacts [Time frame: baseline]
Secondary outcome measures (5)
  • 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]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Other

Study locations

China · 44 centers
  • Xinpu New Area Center of Disease Control — Zunyi
  • Dafang Center for Disease Control and Prevention — Bijie
  • Qixingguan Center for Disease Control and Prevention — Bijie
  • Nayong Center for Disease Control and Prevention — Bijie
  • Hezhang Center for Disease Control — Bijie
  • Jinsha Center for Disease Control — Bijie
  • Qianxi Center of Disease Control — Bijie
  • Weining Center of Disease Control — Bijie
  • … and 36 more centers

Identifiers

NCT: NCT06033807 · TB-Youth Screening

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗