Active Screening of Latent Tuberculosis Infection in School Contacts of Active Tuberculosis Patients
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age13+
SponsorHuashan Hospital
About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Current clinical or sputum culture confirmed active tuberculosis
Have completed a full course of treatment for ATB or LTBI
Trial population
Students in junior middle schools, high schools and universities from Guizhou Province, China
Trial design
Design model
Other
Time perspective
Cross-sectional
Treatments tested in this trial
QuantiFERON-TB Gold (QFT) test
Diagnostic testParticipants 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.
Treatment groups
31,440 Participants
are divided into 1 treatment groupGroup A: Contacts1 intervention
Trial outcomes
Primary outcomes
1
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).
Time frame
baselineSecondary outcomes
1
Age
Age as possible risk factor of tuberculosis infection
Time frame
baseline2
Sex
Sex as possible risk factor of tuberculosis infection.
Time frame
baseline3
Vaccination history checklist
Bacillus Calmette-Guérin (BCG) vaccination history as possible risk factor of tuberculosis infection.
Time frame
baseline4
Patterns of contacting checklist
Duration, size of space of exposure to active tuberculosis-infected patient; as possible risk factor of tuberculosis infection.
Time frame
baselineSponsors and contacts
Click on the lead sponsor to view all of their trials.
Huashan Hospital
Lead sponsor
Guizhou Center for Disease Control and Prevention
Collaborator
Source ClinicalTrials.gov