NCT06874725

Latent Tuberculosis in Type 2 Diabetes

Directly Observed Preventive Therapy (DOPT) for Latent Tuberculosis Infection Patients With Poorly Controlled Diabetes Mellitus

• Status: Active Not Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 552 (actual)
• Sponsor: Taichung Veterans General Hospital · Academic / Other
• Sex: All
• Age: 45 Years
• Healthy volunteers: Not accepted

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.

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

Interventions

Type	Name	Description
DRUG	Rifapentine and Isoniazid for 3 months	tuberculosis preventive therapy (TPT) with 3 months of weekly rifapentine plus isoniazid (3HP)
DRUG	Isoniazid (INH) daily for 9 months	tuberculosis preventive therapy (TPT) with 9 months of daily isoniazid (9H)

Timeline

• Start date: 2018-04-18
• Primary completion: 2024-04-30
• Completion: 2025-04-18
• First posted: 2025-03-13
• Last updated: 2025-03-13

Locations

1 site across 1 country: Taiwan