Children LTBIPhase 1NCT04156568
A Multicentre, Cohort Study of Screening and Preventive Intervention for Latent Tuberculosis Infection in Children
A Phase 1 study testing INH、RFT in people with Children LTBI, run by Beijing Children's Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 day to 18 years
- Conditions the study is for
- Children LTBI
- What is being tested?
- INH、RFT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2018to 31 Dec 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Children (0-18 years old).
- Children with QFT-positive or TST induration ≥10 mm).
Who cannot join
- Patients are allergic to anti-tuberculsis drugs.
- Parents and/or guardians do not agree to participate in this study.
- Participants with active tuberculosis.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Children's Hospital of Capital Medical University
Beijing
Adong Shen, Master, 13370115087, shenad16@hotmail.com
About this study
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.
Read the detailed description
- 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.
- 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
- Conditions
- Children LTBI
- Being tested
- INH、RFT
- Keywords
- Children, LTBI, Intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INH、RFTDrug
6INH 10mg/kg 3INH+RFT 15mg/kg
| Study group | Role | What they receive |
|---|---|---|
| 6INH Group | Experimental | 10mg/kg 6INH were used in this group. Receives: Drug: INH、RFT |
| 3INH+RFT group | Experimental | 3INH+RFTwere used in this grroup. Receives: Drug: INH、RFT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Morbidity
Percentage of latent TB infections converted to active TB
Measured: During the 2 year follow-up study
Proportion of adverse reactions
The incidence of adverse reactions in different treatment regimens
Measured: During the 2 year follow-up study
Proportion of lost to follow-up
The proportion of lost to follow-up in different treatment regimens
Measured: During the 2 year follow-up study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2019
- Study start1 Nov 2018
- Primary completion1 Sep 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Children LTBIStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adong Shen, Beijing Children's Hospital
- Investigators
- A-Dong Shen, Master, Principal investigator, Beijing Children's Hospital of Capital Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04156568
- Sponsor's protocol ID
- BCH_LTBI study 001
- Status last verified
- Nov 2019
- First submitted
- 6 Nov 2019
- Last updated
- 7 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre, Cohort Study of Screening and Preventive Intervention for Latent Tuberculosis Infection in Children
- ClinicalTrials.gov ID
- NCT04156568
- Acronym / sponsor ID
- BCH_LTBI study 001
- Conditions
- Children LTBI
- Keywords
- Children, LTBI, Intervention
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Beijing Children's HospitalUniversity, hospital or other
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 1 Sep 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 7 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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.
- 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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 6INH Group | Experimental | Drug: INH、RFT10mg/kg 6INH were used in this group. |
| 3INH+RFT group | Experimental | Drug: INH、RFT3INH+RFTwere used in this grroup. |
Who may qualify
- Ages
- 1 day to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Children (0-18 years old).
- Children with QFT-positive or TST induration ≥10 mm).
Key exclusion criteria (3 listed)
- Patients are allergic to anti-tuberculsis drugs.
- Parents and/or guardians do not agree to participate in this study.
- Participants with active tuberculosis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| INH、RFT6INH 10mg/kg 3INH+RFT 15mg/kg | Drug | 3INH+RFT group, 6INH Group |
Primary outcome
Morbidity
Time frame: During the 2 year follow-up study
Percentage of latent TB infections converted to active TB
Proportion of adverse reactions
Time frame: During the 2 year follow-up study
The incidence of adverse reactions in different treatment regimens
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
A-Dong Shen, Master principal investigator
Beijing Children's Hospital of Capital Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing INH、RFT in people with Children LTBI, run by Beijing Children's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact A-Dong Shen, Master (+86-010-59616898, shenad16@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Morbidity (time frame: During the 2 year follow-up study). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2019.