NCT06874725

Brief 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. The completion rates and inflammatory markers were also investigated.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
552

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Apr 2018

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 18, 2018

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2024

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

March 8, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 13, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 18, 2025

Completed
Last Updated

March 13, 2025

Status Verified

March 1, 2025

Enrollment Period

6 years

First QC Date

March 8, 2025

Last Update Submit

March 8, 2025

Conditions

Latent Tuberculosis Infection

Keywords

Latent tuberculosis infectiondiabetesobservational study

Outcome Measures

Primary Outcomes (1)

  • Brain-Derived Neurotrophic Factor

    Biomarker

    9 months

Secondary Outcomes (1)

  • Inflammatory markers

    9 months

Study Arms (2)

3 months of weekly rifapentine plus isoniazid

ACTIVE COMPARATOR

3 months of weekly rifapentine plus isoniazid

Drug: Rifapentine and Isoniazid for 3 months

9 months of daily isoniazid

ACTIVE COMPARATOR

9 months of daily isoniazid

Drug: Isoniazid (INH) daily for 9 months

Interventions

Rifapentine and Isoniazid for 3 monthsDRUG

tuberculosis preventive therapy (TPT) with 3 months of weekly rifapentine plus isoniazid (3HP)

Also known as: 3HP
3 months of weekly rifapentine plus isoniazid
Isoniazid (INH) daily for 9 monthsDRUG

tuberculosis preventive therapy (TPT) with 9 months of daily isoniazid (9H)

Also known as: 9H
9 months of daily isoniazid

Eligibility Criteria

Age45 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • aged ≥45 years
  • poorly controlled DM (pDM), defined as HbA1c ≥9% within the preceding year

You may not qualify if:

  • active TB
  • immunocompromise (use of immunosuppressors
  • current pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taichung Veterans General Hospital

Taichung, 407219, Taiwan

Location

MeSH Terms

Conditions

Latent TuberculosisDiabetes Mellitus

Interventions

rifapentineIsoniazid

Condition Hierarchy (Ancestors)

TuberculosisMycobacterium InfectionsActinomycetales InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsLatent InfectionGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

HydrazinesOrganic ChemicalsIsonicotinic AcidsAcids, HeterocyclicHeterocyclic CompoundsPyridinesHeterocyclic Compounds, 1-Ring

Study Officials

  • I-Te Lee

    Taichung Veterans General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 8, 2025

First Posted

March 13, 2025

Study Start

April 18, 2018

Primary Completion

April 30, 2024

Study Completion

April 18, 2025

Last Updated

March 13, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)