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临床试验/NCT02875574
NCT02875574已完成不适用

Improving the Management of Drug Resistant Tuberculosis in the UK

University College, London1 个研究点 分布在 1 个国家目标入组 630 人开始时间: 2016年11月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
630
试验地点
1
主要终点
Treatment outcome

研究概览

简要总结

The 'rising tide' of antimicrobial resistance is a source of concern across most infectious diseases. In the UK, for example, 6.8% of the ~8,500 tuberculosis patients seen in 2012 were resistant to the cheap and effective first-line drug isoniazid. It is of great importance to prevent the loss of current anti-tuberculosis drugs and preventing the spread of resistance by treating such patients as well as possible.

Currently, guidance on the best treatments for isoniazid resistant tuberculosis is inconsistent globally. Data from randomised controlled trials, the peak quality of evidence, is sparse. It is thus important that studies using pre-existing observational data are undertaken.

The investigators aim to use data and samples collected from Public Health England and National Health Service hospitals to determine a) the best treatments for patients with isoniazid resistant tuberculosis disease (cohort study) and b) how different causes of drug resistance in the infecting bacteria influence a) (nested case-control study). Eligible participants will have had isoniazid resistant tuberculosis (without associated rifampicin resistance) in England between 2009 and 2013 and will have been notified to Public Health England. The study will be conducted at University College London, National Health Service hospitals and Public Health England and will last until December 2017. Patient hospital records and disease surveillance records will be accessed and cultured bacteria from previously stored samples sequenced.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

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

  • Isoniazid resistant non-multidrug resistant tuberculosis patients.
  • Notified to Public Health England's Enhanced Tuberculosis Surveillance System between 2009-
  • Adults aged 18 years and over.
  • Patients not treated at private hospitals.

排除标准

  • Non-notified patients.
  • Individuals where the site of disease required more than 12 months of treatment.
  • Individuals diagnosed post-mortem.

研究组 & 干预措施

All participants

干预措施: Any treatment regimen (Drug)

All participants

干预措施: Bacterial mutation (Other)

结局指标

主要结局

Treatment outcome

时间窗: Up to 12 months after the start of treatment

Negative versus positive treatment outcomes attributable to the treatment regimen commenced once isoniazid resistance known. Taken from clinical records. Also used to define cases and controls for nested case-control study.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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