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

NCT ID: NCT04156568

Last Updated: 2019-11-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

1000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-01

Study Completion Date

2021-12-31

Brief Summary

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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

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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

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Children LTBI

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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6INH Group

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

Group Type EXPERIMENTAL

INH、RFT

Intervention Type DRUG

6INH 10mg/kg 3INH+RFT 15mg/kg

3INH+RFT group

3INH+RFTwere used in this grroup.

Group Type EXPERIMENTAL

INH、RFT

Intervention Type DRUG

6INH 10mg/kg 3INH+RFT 15mg/kg

Interventions

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INH、RFT

6INH 10mg/kg 3INH+RFT 15mg/kg

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

1 Day

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beijing Children's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Adong Shen

Deputy Chief of China National Clinical Research Center for Respiratory Diseases

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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A-Dong Shen, Master

Role: PRINCIPAL_INVESTIGATOR

Beijing Children's Hospital of Capital Medical University

Locations

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Beijing Children's Hospital of Capital Medical University

Beijing, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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A-Dong Shen, Master

Role: CONTACT

+86-010-59616898

Facility Contacts

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Adong Shen, Master

Role: primary

13370115087

Other Identifiers

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BCH_LTBI study 001

Identifier Type: -

Identifier Source: org_study_id

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