3HP, Adverse Reaction to Drug
Conditions
Brief summary
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.
Interventions
DRUG3HP
all patients taking 3HP under directly observed preventive therapy (DOPT) program
Sponsors
Chang Gung Memorial Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
20 Years to 100 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| sTREM1 between >= grade 2 adverse reaction (SAR group) and< grade 2 adverse reaction (Non-SAR group) | Change from Baseline sTREM1 at 2 weeks |
| sTREM2 between >= grade 2 adverse reaction (SAR group) and< grade 2 adverse reaction (Non-SAR group) | Change from Baseline sTREM1 at 2 weeks |
Countries
Taiwan
Contacts
Primary ContactTsai-Yu Wang
Outcome results
None listed