Clinical Analysis of Safety in Latent Tuberculosis Infection Prophylaxis Treatment
NCT ID: NCT04655794
Last Updated: 2020-12-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
500 participants
OBSERVATIONAL
2018-04-19
2021-02-12
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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had >= grade 2 adverse reactions
3HP
all patients taking 3HP under directly observed preventive therapy (DOPT) program
had <2 frade 2 adverse reactions
3HP
all patients taking 3HP under directly observed preventive therapy (DOPT) program
Interventions
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3HP
all patients taking 3HP under directly observed preventive therapy (DOPT) program
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
20 Years
100 Years
ALL
No
Sponsors
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Chang Gung Memorial Hospital
OTHER
Responsible Party
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Locations
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Institutional Review Board Chang Gung Medical Foundation
Taipei, , Taiwan
Countries
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Central Contacts
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Facility Contacts
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Tsai-Yu Wang, MD
Role: primary
References
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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.
Other Identifiers
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201800081B0
Identifier Type: -
Identifier Source: org_study_id