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

November 6, 2019 updated by: Adong Shen, Beijing Children's Hospital
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

1000

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China
        • Recruiting
        • Beijing Children's Hospital of Capital Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 day to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 6INH Group
10mg/kg 6INH were used in this group.
Drug: INH、RFT
6INH 10mg/kg 3INH+RFT 15mg/kg
Experimental: 3INH+RFT group
3INH+RFTwere used in this grroup.
Drug: INH、RFT
6INH 10mg/kg 3INH+RFT 15mg/kg

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing Children's Hospital

Investigators

  • Principal Investigator: A-Dong Shen, Master, Beijing Children's Hospital of Capital Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2018

Primary Completion (Anticipated)

September 1, 2021

Study Completion (Anticipated)

December 31, 2021

Study Registration Dates

First Submitted

November 6, 2019

First Submitted That Met QC Criteria

November 6, 2019

First Posted (Actual)

November 7, 2019

Study Record Updates

Last Update Posted (Actual)

November 7, 2019

Last Update Submitted That Met QC Criteria

November 6, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BCH_LTBI study 001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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