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

Children LTBI Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04156568
• Other study ID #: BCH_LTBI study 001
• Status: Recruiting
• Phase: Phase 1
• Start date: November 1, 2018
• Est. completion date: December 31, 2021

Study information

• Verified date: November 2019
• Source: Beijing Children's Hospital
• Contact: A-Dong Shen, Master
• Phone: +86-010-59616898
• Email: shenad16[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: December 31, 2021
• Est. primary completion date: September 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Children LTBI
• Latent Tuberculosis
• Tuberculosis

Intervention

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

Locations

Country	Name	City	State
China	Beijing Children's Hospital of Capital Medical University	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Children's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Morbidity	Percentage of latent TB infections converted to active TB	During the 2 year follow-up study
Primary	Proportion of adverse reactions	The incidence of adverse reactions in different treatment regimens	During the 2 year follow-up study
Primary	Proportion of lost to follow-up	The proportion of lost to follow-up in different treatment regimens	During the 2 year follow-up study