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临床试验/NCT01182259
NCT01182259Unknown不适用

The Incidence and Risk Factors of Side Effects During the Initial Phase of Rifater Therapy - a Prospective Study

E-DA Hospital1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2009年10月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
200
试验地点
1

研究概览

简要总结

Tuberculosis remains one of the largest health problems in the world today. Multidrug therapy is necessary to cure tuberculosis patients and to prevent the selection of drug-resistant mutants, however, which may increase the incidence of side effects during the course of treatment. These side effects may be mild as well as fatal. A severe side effect against one of the anti-TB drugs, which influences drug compliance, may lead to the discontinuation of that drug. At the same time, the risk of treatment failure and relapse are higher. Therefore monitoring the rate of anti-TB drugs induced adverse effects and the related risk factors is crucial. Awareness of the risk groups may decrease the incidence of serious drug-related side effects and medical cost.

The fixed-dose combinations (FDCs) of tablets against tuberculosis is now being recommended by WHO, which simplify the prescription of drugs and prevent the development of drug resistance. However, the FDC regimen is not consistent with the dosages that are usually given, the higher risk of drug toxicity and adverse reactions should be considered. To our knowledge, there was no report to assess the adverse effects of FDC anti-TB drugs in Taiwan. The aim of the present study is to investigate the current incidence of side effects and the risk factors related to FDC drugs for side effects during the initial phase of therapy.

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
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Newly diagnosed pulmonary TB and extrapulmonary TB patients
  • No previous anti-TB drugs treatment
  • Age more than 18years old

排除标准

  • Expected life < 6months
  • Baseline AST and ALT > 3 fold upper limit of normal (ULN) or total bilirubin>2mg/dl
  • Age less than 18years old

研究者

发起方
E-DA Hospital
申办方类型
Other

研究点 (1)

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