A Multicentre, Cohort Study of Screening and Preventive Intervention for Latent Tuberculosis Infection in Children

Study Overview
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Brief Summary
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The management of latent Mycobacterium tuberculosis infection is a new priority action for the WHO End Tuberculosis (TB) Strategy. However, national guidelines on latent tuberculosis infection testing and treatment have not yet been developed in children of China. Here, we present the results from the 3-year follow-up of a study that aimed to track the development of active disease in individuals with latent tuberculosis infection, identify priority populations for latent infection management, and explore the most suitable latent infection diagnostic approach.

Detailed Description
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1. Baseline analysis of a population-based, multicentre, prospective cohort study A baseline survey of a population-based, multicentre, prospective cohort study were took in children (≤18). Eligible participants were identifi ed by door-to-door survey with a household sampling design. 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 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. Follow-up study were conducted to assess the proportion of latent TB infection converted to active TB

Official Title
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A Multicentre, Cohort Study of Screening and Preventive Intervention for Latent Tuberculosis Infection in Children

Conditions
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Children LTBI

Intervention / Treatment
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* Drug: INH、RFT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children (0-18 years old). Children with QFT-positive or TST induration ≥10 mm). Exclusion Criteria: Patients are allergic to anti-tuberculsis drugs. Parents and/or guardians do not agree to participate in this study. Participants with active tuberculosis.

Ages Eligible for Study
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Minimum Age: 1 Day
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 6INH Group<br>10mg/kg 6INH were used in this group. | Drug: INH、RFT<br>* 6INH 10mg/kg 3INH+RFT 15mg/kg<br>|
| Experimental: 3INH+RFT group<br>3INH+RFTwere used in this grroup. | Drug: INH、RFT<br>* 6INH 10mg/kg 3INH+RFT 15mg/kg<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Morbidity | Percentage of latent TB infections converted to active TB | During the 2 year follow-up study | 
| Proportion of adverse reactions | The incidence of adverse reactions in different treatment regimens | During the 2 year follow-up study | 
| Proportion of lost to follow-up | The proportion of lost to follow-up in different treatment regimens | During the 2 year follow-up study | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Children, LTBI, Intervention