Clinical Analysis of Safety in Latent Tuberculosis Infection Prophylaxis Treatment

Chang Gung Medical Foundation

Status: Unknown

Conditions: Adverse Reaction to Drug; 3HP

Treatments: Drug: 3HP

Study type: Observational

Funder types: Other

Identifiers

NCT04655794

201800081B0

Details and patient eligibility

About

The treatment of latent TB with 3HP is an important issue for the prevention of active TB. However, significant proportion of subjects receiving 3HP had adverse reaction. The main purpose of this observation study is to identify subjects who have higher risk to develop adverse reaction. Clinical characteristics and biomarker will be used to predict adverse reaction.

Enrollment: 500 estimated patients

Sex: All

Ages: 20 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• close contact with active TB patients
• patients with autoimmune diseases preceding biological therapy
• health-care workers
• other clinical conditions, which increased the risk of LTBI. LTBI was confirmed by QuantiFERON-TB Gold In-Tube test (QFT-GIT; Qiagen, Valencia, CA, USA) with a cut-off value of 0.35 IU/ml.

Exclusion criteria

• age less than 20 years
• pregnant women
• active TB or suspected active TB in the clinical evaluation
• severe liver disease
• ESRD
• organ transplantation
• close contact with a multidrug-resistant TB patient
• obesity (BMI>30 Kgw/m2) and other conditions inappropriate for participation in this study as judged by the investigators.

Trial design

500 participants in 2 patient groups

had >= grade 2 adverse reactions

Treatment:

Drug: 3HP

had <2 frade 2 adverse reactions

Treatment:

Drug: 3HP