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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| had >= grade 2 adverse reactions |
| ||
| had <2 frade 2 adverse reactions |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 3HP | Drug | all patients taking 3HP under directly observed preventive therapy (DOPT) program |
|
| Measure | Description | 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 | |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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The newly identified LTBI subjects who wanted to receive LTBI preventive therapy with 3HP were eligible for enrolment.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tsai-Yu Wang | Contact | +886975368076 | wang5531@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institutional Review Board Chang Gung Medical Foundation | Recruiting | Taipei | 333 | Taiwan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35308376 | Derived | Wang TY, Feng JY, Shu CC, Lee SS, Chen CY, Wei YF, Lin CB, Huang WC, Su WJ, Lin SM. Plasma Concentrations of sTREM-1 as Markers for Systemic Adverse Reactions in Subjects Treated With Weekly Rifapentine and Isoniazid for Latent Tuberculosis Infection. Front Microbiol. 2022 Mar 3;13:821066. doi: 10.3389/fmicb.2022.821066. eCollection 2022. |
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| ID | Term |
|---|---|
| D064420 | Drug-Related Side Effects and Adverse Reactions |
| ID | Term |
|---|---|
| D064419 | Chemically-Induced Disorders |
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