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

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

Status
UNKNOWN
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04156568
Enrollment
1000
Registered
2019-11-07
Start date
2018-11-01
Completion date
2021-12-31
Last updated
2019-11-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Children LTBI

Keywords

Children, LTBI, Intervention

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

Interventions

DRUGINH、RFT

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

Sponsors

Beijing Children's Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
1 Days to 18 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
MorbidityDuring the 2 year follow-up studyPercentage of latent TB infections converted to active TB
Proportion of adverse reactionsDuring the 2 year follow-up studyThe incidence of adverse reactions in different treatment regimens
Proportion of lost to follow-upDuring the 2 year follow-up studyThe proportion of lost to follow-up in different treatment regimens

Countries

China

Contacts

Primary ContactA-Dong Shen, Master
shenad16@hotmail.com+86-010-59616898

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026