Latent Tuberculosis InfectionPhase 4TBNCT06874725
Latent Tuberculosis in Type 2 Diabetes
A Phase 4 study testing Rifapentine and Isoniazid for 3 months and Isoniazid (INH) daily for 9 months in people with Latent Tuberculosis Infection, run by Taichung Veterans General Hospital at 1 site in Taiwan.
Trial summary
The patients with poorly controlled DM underwent LTBI screening by using QuantiFERON (QFT). QFT-positivity predictors were evaluated. The patients with LTBI received tuberculosis preventive therapy, 9 months of daily isoniazid (9H) or 3 months of weekly rifapentine plus isoniazid (3HP), administered by pulmonologists. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Latent Tuberculosis Infection
- What is being tested?
- Rifapentine and Isoniazid for 3 months and Isoniazid (INH) daily for 9 months
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 552 participants
- Where
- 1 siteTaiwan
- Study dates
- 18 Apr 2018to 18 Apr 2025
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- aged ≥45 years
- poorly controlled DM (pDM), defined as HbA1c ≥9% within the preceding year
Who cannot join
- active TB
- immunocompromise (use of immunosuppressors
- current pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Directly Observed Preventive Therapy (DOPT) for Latent Tuberculosis Infection Patients With Poorly Controlled Diabetes Mellitus
The patients with poorly controlled DM underwent LTBI screening by using QuantiFERON (QFT). QFT-positivity predictors were evaluated. The patients with LTBI received tuberculosis preventive therapy, 9 months of daily isoniazid (9H) or 3 months of weekly rifapentine plus isoniazid (3HP), administered by pulmonologists. The completion rates and inflammatory markers were also investigated.
Read the detailed description
Poor control of diabetes mellitus (DM) increases active tuberculosis (TB) risk. Understanding risk factors for latent TB infection (LTBI) in this population is crucial for policy making. Under a collaborative multidisciplinary team consisting of endocrinologists and pulmonologists, patients with poorly controlled DM were enrolled; these patients underwent LTBI screening by using QuantiFERON (QFT). QFT-positivity predictors were evaluated. The patients with LTBI received tuberculosis preventive therapy, 9 months of daily isoniazid (9H) or 3 months of weekly rifapentine plus isoniazid (3HP), administered by pulmonologists. The completion rates and inflammatory markers were also investigated.
- Conditions
- Latent Tuberculosis Infection
- Being tested
- Rifapentine and Isoniazid for 3 months, Isoniazid (INH) daily for 9 months
- Keywords
- Latent tuberculosis infection, diabetes, observational study
- Medical subject headings
- Latent Tuberculosis, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rifapentine and Isoniazid for 3 monthsDrug
Also called 3HP
tuberculosis preventive therapy (TPT) with 3 months of weekly rifapentine plus isoniazid (3HP)
Isoniazid (INH) daily for 9 monthsDrug
Also called 9H
tuberculosis preventive therapy (TPT) with 9 months of daily isoniazid (9H)
| Study group | Role | What they receive |
|---|---|---|
| 3 months of weekly rifapentine plus isoniazid | Active comparator | 3 months of weekly rifapentine plus isoniazid Receives: Drug: Rifapentine and Isoniazid for 3 months |
| 9 months of daily isoniazid | Active comparator | 9 months of daily isoniazid Receives: Drug: Isoniazid (INH) daily for 9 months |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brain-Derived Neurotrophic Factor
Biomarker
Measured: 9 months
Secondary outcomes (1)
Inflammatory markers
aryl hydrocarbon receptor, adhesion molecules, dickkopf-related protein 1
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2025
- Study start18 Apr 2018
- Primary completion30 Apr 2024
- Study completion18 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Latent Tuberculosis InfectionStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 552 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taichung Veterans General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- I-Te Lee, Principal investigator, Taichung Veterans General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06874725
- Sponsor's protocol ID
- TCVGH-CE18090B
- Acronym
- TB
- Status last verified
- Mar 2025
- First submitted
- 8 Mar 2025
- Last updated
- 13 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Directly Observed Preventive Therapy (DOPT) for Latent Tuberculosis Infection Patients With Poorly Controlled Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT06874725
- Acronym / sponsor ID
- TB / TCVGH-CE18090B
- Conditions
- Latent Tuberculosis Infection
- Keywords
- Latent tuberculosis infection, diabetes, observational study
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 552 participants (actual)
- Lead sponsor
- Taichung Veterans General HospitalUniversity, hospital or other
- Study start
- 18 Apr 2018 (actual)
- Primary completion
- 30 Apr 2024 (actual)
- Study completion
- 18 Apr 2025 (estimated)
- First posted
- 13 Mar 2025 (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 patients with poorly controlled DM underwent LTBI screening by using QuantiFERON (QFT). QFT-positivity predictors were evaluated. The patients with LTBI received tuberculosis preventive therapy, 9 months of daily isoniazid (9H) or 3 months of weekly rifapentine plus isoniazid (3HP), administered by pulmonologists. The completion rates and inflammatory markers were also investigated.
Detailed description
Poor control of diabetes mellitus (DM) increases active tuberculosis (TB) risk. Understanding risk factors for latent TB infection (LTBI) in this population is crucial for policy making. Under a collaborative multidisciplinary team consisting of endocrinologists and pulmonologists, patients with poorly controlled DM were enrolled; these patients underwent LTBI screening by using QuantiFERON (QFT). QFT-positivity predictors were evaluated. The patients with LTBI received tuberculosis preventive therapy, 9 months of daily isoniazid (9H) or 3 months of weekly rifapentine plus isoniazid (3HP), administered by pulmonologists. The completion rates and inflammatory markers were also investigated.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 3 months of weekly rifapentine plus isoniazid | Active comparator | Drug: Rifapentine and Isoniazid for 3 months3 months of weekly rifapentine plus isoniazid |
| 9 months of daily isoniazid | Active comparator | Drug: Isoniazid (INH) daily for 9 months9 months of daily isoniazid |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- aged ≥45 years
- poorly controlled DM (pDM), defined as HbA1c ≥9% within the preceding year
Key exclusion criteria (3 listed)
- active TB
- immunocompromise (use of immunosuppressors
- current pregnancy
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 |
|---|---|---|
| Rifapentine and Isoniazid for 3 monthsAlso: 3HPtuberculosis preventive therapy (TPT) with 3 months of weekly rifapentine plus isoniazid (3HP) | Drug | 3 months of weekly rifapentine plus isoniazid |
| Isoniazid (INH) daily for 9 monthsAlso: 9Htuberculosis preventive therapy (TPT) with 9 months of daily isoniazid (9H) | Drug | 9 months of daily isoniazid |
Primary outcome
Brain-Derived Neurotrophic Factor
Time frame: 9 months
Biomarker
1 secondary outcome
Inflammatory markers
Time frame: 9 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2025.
- Individual participant dataSharing planned: No
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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.
I-Te Lee principal investigator
Taichung Veterans General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Rifapentine and Isoniazid for 3 months and Isoniazid (INH) daily for 9 months in people with Latent Tuberculosis Infection, run by Taichung Veterans General Hospital at 1 site in Taiwan.
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: under way, not looking for participants, as of the sponsor's last update on 13 Mar 2025. 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 Taiwan. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brain-Derived Neurotrophic Factor (time frame: 9 months). 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 13 Mar 2025.