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

Capital Medical University

Status and phase: Unknown; Phase 1

Conditions: Children LTBI

Treatments: Drug: INH、RFT

Study type: Interventional

Funder types: Other

Identifiers

NCT04156568

BCH_LTBI study 001

Details and patient eligibility

About

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.

Full description

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

2. A baseline survey of a population-based, multicentre, prospective cohort study were took in children (≤18).

3. Eligible participants were identifi ed by door-to-door survey with a household sampling design.

4. 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.

5. Incidence of active tuberculosis in individuals with latent tuberculosis infection in children of China under different treatment regimens

6. 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.

7. Follow-up study were conducted to assess the proportion of latent TB infection converted to active TB

Enrollment: 1,000 estimated patients

Sex: All

Ages: 1 day to 18 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1,000 participants in 2 patient groups

6INH Group

Experimental group

Description:

10mg/kg 6INH were used in this group.

Treatment:

Drug: INH、RFT

3INH+RFT group

Experimental group

Description:

3INH+RFTwere used in this grroup.

Treatment:

Drug: INH、RFT