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

Phase 1

• Conditions: Children LTBI
• Interventions: Drug: INH、RFT

• Registration Number: NCT04156568
• Lead Sponsor: Beijing Children's Hospital

Brief 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

Study Timeline

• Study Start: 2018-11-01
• Status Verified: 2019-11
• Study First Submitted: 2019-11-06
• Study First Submitted QC: 2019-11-06
• Last Update Submitted: 2019-11-06
• Study First Posted: 2019-11-07
• Last Update Posted: 2019-11-07
• Primary Completion: 2021-09-01
• Study Completion: 2021-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1000

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
3INH+RFT group	INH、RFT	3INH+RFTwere used in this grroup.
6INH Group	INH、RFT	10mg/kg 6INH were used in this group.

Primary Outcome Measures

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

Trial Locations

Locations (1)

Beijing Children's Hospital of Capital Medical University; 🇨🇳 Beijing, China