Clinical Analysis of Safety in Latent Tuberculosis Infection Prophylaxis Treatment
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
had >= grade 2 adverse reactions
|
Drug: 3HP
all patients taking 3HP under directly observed preventive therapy (DOPT) program
|
had <2 frade 2 adverse reactions
|
Drug: 3HP
all patients taking 3HP under directly observed preventive therapy (DOPT) program
|
Outcome Measures
Primary Outcome Measures
- sTREM1 between >= grade 2 adverse reaction (SAR group) and< grade 2 adverse reaction (Non-SAR group) [Change from Baseline sTREM1 at 2 weeks]
- sTREM1 between >= grade 2 adverse reaction (SAR group) and< grade 2 adverse reaction (Non-SAR group) [Change from Baseline sTREM1 at SARs]
- sTREM2 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 SARs]
Eligibility Criteria
Criteria
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.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Institutional Review Board Chang Gung Medical Foundation | Taipei | Taiwan | 333 |
Sponsors and Collaborators
- Chang Gung Memorial Hospital
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 201800081B0