Ignite Creation Date:
2025-12-24 @ 5:56 PM
Ignite Modification Date:
2025-12-24 @ 5:56 PM
Study NCT ID:
NCT04156568
Status:
UNKNOWN
Last Update Posted:
2019-11-07
First Post:
2019-11-06
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Multicentre, Cohort Study of Screening and Preventive Intervention for Latent Tuberculosis Infection in Children
Sponsor:
Beijing Children's Hospital
Organization:
Study Overview
Official Title:
A Multicentre, Cohort Study of Screening and Preventive Intervention for Latent Tuberculosis Infection in Children
Status:
UNKNOWN
Status Verified Date:
2019-11
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: