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临床试验/NCT03312647
NCT03312647Unknown不适用

Adverse Drug Reactions to Antituberculosis Drugs in the Treatment of Latent Tuberculosis Infection in Korean Health Care Workers

Hanyang University1 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2017年6月19日最近更新:
适应症

试验速览

阶段
不适用
入组人数
1,000
试验地点
1
主要终点
The numbers of adverse drug reactions (ADR) during LTBI treatment

研究概览

简要总结

The investigators aim to study the prevalence of adverse reactions of anti-tuberculosis (TB) drugs in latent tuberculosis infection (LTBI), and determine the risk factors of anti-TB drug-related toxicity in LTBI in Korean health care workers(HCWs).

详细描述

Further study details as provided by Hanyang University Hospital

This study is prospective study of newly diagnosed LTBI in HCWs at Hanyang University Hospital, a tertiary referral hospital in South Korea, between 2017 and 2018. This study aimed to identify the prevalence of adverse reactions of treatment regimen for LTBI. The diagnosis of LTBI was made on the basis of interferon-gamma releasing assay. Information on demographic characteristics, comorbidity and treatment outcomes was collated from questionnaires. Treatment regimen for LTBI was chosen by patients' preference among 3 months of INH(isoniazid) plus RFP(rifampin), 4 months of RFP and 9 months of INH. All PTB patients were observed 2 weeks after the initiation of medication, and monthly thereafter, and were asked about any drug side effects at these visits. Serious adverse drug reaction (ADR) was defined as any severe side effect that resulted in discontinuation or change (either temporally or permanently) of anti-TB medication, and/or directly resulted in hospitalization. Drug-induced hepatitis was defined as liver transaminases more than three times higher than the upper limit of normal in the presence of symptoms such as anorexia, nausea, vomiting, or abdominal pain, or transaminases more than five times the upper limit of normal without symptoms.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
19 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 19 years or more
  • Identified latent tuberculosis infection (LTBI) in Korean health care workers, using whole-blood interferon-r release assays

排除标准

  • Subjects who do not want to participate the present study
  • Subjects who do not receive LTBI treatment due to abnormal liver function test (i.e, liver cirrhosis etc)
  • Subjects with history of previously treated TB
  • Subjects with active tuberculosis infection

结局指标

主要结局

The numbers of adverse drug reactions (ADR) during LTBI treatment

时间窗: one year

All events of adverse drug reactions (ADR) were reported using the clinical signs, symptoms, and liver chemistry at predefined intervals (two weeks after the initiation of anti-TB drugs, and monthly thereafter).

次要结局

  • The numbers of severe ADR during LTBI treatment(one year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dong Won Park

Assistant professor

Hanyang University

研究点 (1)

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