A Multicentre, Cohort Study of Screening and Preventive Intervention for Latent Tuberculosis Infection in Children
NCT ID: NCT04156568
Last Updated: 2019-11-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1
1000 participants
INTERVENTIONAL
2018-11-01
2021-12-31
Brief Summary
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Detailed Description
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1. A baseline survey of a population-based, multicentre, prospective cohort study were took in children (≤18).
2. Eligible participants were identifi ed by door-to-door survey with a household sampling design.
3. Participants were screened for active tuberculosis and history of tuberculosis then used a tuberculin skin test and an interferon-γ release assay (QuantiFERON \[QFT\]) to test for latent infection.
2\. Incidence of active tuberculosis in individuals with latent tuberculosis infection in children of China under different treatment regimens
1. Individuals who had tuberculosis infection at baseline (QFT-positivity or TST tuberculin reaction size \[induration\] of ≥10 mm) were divided and treatment with different therapeutic schedule.
2. Follow-up study were conducted to assess the proportion of latent TB infection converted to active TB
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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6INH Group
10mg/kg 6INH were used in this group.
INH、RFT
6INH 10mg/kg 3INH+RFT 15mg/kg
3INH+RFT group
3INH+RFTwere used in this grroup.
INH、RFT
6INH 10mg/kg 3INH+RFT 15mg/kg
Interventions
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INH、RFT
6INH 10mg/kg 3INH+RFT 15mg/kg
Eligibility Criteria
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Inclusion Criteria
* Children with QFT-positive or TST induration ≥10 mm).
Exclusion Criteria
* Parents and/or guardians do not agree to participate in this study.
* Participants with active tuberculosis.
1 Day
18 Years
ALL
No
Sponsors
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Beijing Children's Hospital
OTHER
Responsible Party
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Adong Shen
Deputy Chief of China National Clinical Research Center for Respiratory Diseases
Principal Investigators
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A-Dong Shen, Master
Role: PRINCIPAL_INVESTIGATOR
Beijing Children's Hospital of Capital Medical University
Locations
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Beijing Children's Hospital of Capital Medical University
Beijing, , China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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BCH_LTBI study 001
Identifier Type: -
Identifier Source: org_study_id
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