Latent Tuberculosis in Type 2 Diabetes (TB)

Taichung Veterans General Hospital

Status and phase: Active, not recruiting; Phase 4

Conditions: Latent Tuberculosis Infection

Treatments: Drug: Rifapentine and Isoniazid for 3 months; Drug: Isoniazid (INH) daily for 9 months

Study type: Interventional

Funder types: Other

Identifiers

NCT06874725

TCVGH-CE18090B

Details and patient eligibility

About

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.

Full 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.

Enrollment: 552 patients

Sex: All

Ages: 45+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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552 participants in 2 patient groups

3 months of weekly rifapentine plus isoniazid

Active Comparator group

Description:

3 months of weekly rifapentine plus isoniazid

Treatment:

Drug: Rifapentine and Isoniazid for 3 months

9 months of daily isoniazid

Active Comparator group

Description:

9 months of daily isoniazid

Treatment:

Drug: Isoniazid (INH) daily for 9 months