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

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Outcomes Assessor)
  • Study Primary Completion Date: September 1, 2021

Detailed Description

1. Baseline analysis of a population-based, multicentre, prospective cohort study

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

Interventions

  • Drug: INH、RFT
    • 6INH 10mg/kg 3INH+RFT 15mg/kg

Arms, Groups and Cohorts

  • Experimental: 6INH Group
    • 10mg/kg 6INH were used in this group.
  • Experimental: 3INH+RFT group
    • 3INH+RFTwere used in this grroup.

Clinical Trial Outcome Measures

Primary Measures

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

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: 18 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Beijing Children’s Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Adong Shen, Deputy Chief of China National Clinical Research Center for Respiratory Diseases – Beijing Children’s Hospital
  • Overall Official(s)
    • A-Dong Shen, Master, Principal Investigator, Beijing Children’s Hospital of Capital Medical University
  • Overall Contact(s)
    • A-Dong Shen, Master, +86-010-59616898, shenad16@hotmail.com

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