NCT04156568

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

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 1,000 (estimated)
• Sponsor: Beijing Children's Hospital · Academic / Other
• Sex: All
• Age: 1 Day – 18 Years
• Healthy volunteers: Not accepted

Summary

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

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

Conditions

• Children LTBI

Interventions

Type	Name	Description
DRUG	INH、RFT	6INH 10mg/kg 3INH+RFT 15mg/kg

Timeline

• Start date: 2018-11-01
• Primary completion: 2021-09-01
• Completion: 2021-12-31
• First posted: 2019-11-07
• Last updated: 2019-11-07

Locations

1 site across 1 country: China