Back to resultsA Multicentre, Cohort Study of Screening and Preventive Intervention for Latent Tuberculosis Infection in Children
Primary Purpose
Children LTBI
Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
INH、RFT
Sponsored by
About this trial
This is an interventional treatment trial for Children LTBI focused on measuring Children, LTBI, Intervention
Eligibility Criteria
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.
Sites / Locations
- Beijing Children's Hospital of Capital Medical UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
6INH Group
3INH+RFT group
Arm Description
10mg/kg 6INH were used in this group.
3INH+RFTwere used in this grroup.
Outcomes
Primary Outcome Measures
Morbidity
Percentage of latent TB infections converted to active TB
Proportion of adverse reactions
The incidence of adverse reactions in different treatment regimens
Proportion of lost to follow-up
The proportion of lost to follow-up in different treatment regimens
Secondary Outcome Measures
Full Information
NCT ID
NCT04156568
First Posted
November 6, 2019
Last Updated
November 6, 2019
Sponsor
Beijing Children's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04156568
Brief Title
A Multicentre, Cohort Study of Screening and Preventive Intervention for Latent Tuberculosis Infection in Children
Official Title
A Multicentre, Cohort Study of Screening and Preventive Intervention for Latent Tuberculosis Infection in Children
Study Type
Interventional
2. Study Status
Record Verification Date
November 2019
Overall Recruitment Status
Unknown status
Study Start Date
November 1, 2018 (Actual)
Primary Completion Date
September 1, 2021 (Anticipated)
Study Completion Date
December 31, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beijing Children's Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
A baseline survey of a population-based, multicentre, prospective cohort study were took in children (≤18).
Eligible participants were identifi ed by door-to-door survey with a household sampling design.
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
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.
Follow-up study were conducted to assess the proportion of latent TB infection converted to active TB
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Children LTBI
Keywords
Children, LTBI, Intervention
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
1000 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
6INH Group
Arm Type
Experimental
Arm Description
10mg/kg 6INH were used in this group.
Arm Title
3INH+RFT group
Arm Type
Experimental
Arm Description
3INH+RFTwere used in this grroup.
Intervention Type
Drug
Intervention Name(s)
INH、RFT
Intervention Description
6INH 10mg/kg 3INH+RFT 15mg/kg
Primary Outcome Measure Information:
Title
Morbidity
Description
Percentage of latent TB infections converted to active TB
Time Frame
During the 2 year follow-up study
Title
Proportion of adverse reactions
Description
The incidence of adverse reactions in different treatment regimens
Time Frame
During the 2 year follow-up study
Title
Proportion of lost to follow-up
Description
The proportion of lost to follow-up in different treatment regimens
Time Frame
During the 2 year follow-up study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
A-Dong Shen, Master
Phone
+86-010-59616898
Email
shenad16@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
A-Dong Shen, Master
Organizational Affiliation
Beijing Children's Hospital of Capital Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beijing Children's Hospital of Capital Medical University
City
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Adong Shen, Master
Phone
13370115087
Email
shenad16@hotmail.com
12. IPD Sharing Statement
Learn more about this trial
A Multicentre, Cohort Study of Screening and Preventive Intervention for Latent Tuberculosis Infection in Children
We'll reach out to this number within 24 hrs