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临床试验/NCT04002869
NCT04002869Unknown不适用

Innovation in Tuberculosis

Fundació Institut Germans Trias i Pujol1 个研究点 分布在 1 个国家目标入组 550 人开始时间: 2019年1月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
550
试验地点
1
主要终点
Diagnostic accuracy

研究概览

简要总结

Tuberculosis (TB) is one of the major infectious diseases worldwide, and the emergence and spread of drug resistant cases is a public health threat. However, the conventional methods used for diagnosis and drug-susceptibility testing are not enough for controlling the disease. In addition, all TB patients, independently of their age, gender, severity of the disease and type of responsible strain, follow the same treatment duration (up to 20 months in drug resistant cases), which often leads to high frequency of adverse events, suboptimal adherence to treatment, and poor outcome. Therefore, a transition from programmatic to personalized management of TB is needed.

INNOVA4TB proposal will develop innovative technologies and approaches in order to improve the individual risk assessment for TB development, to rapidly diagnose active TB, to detect the drug susceptibility of the strain, to design tailor-made therapies, and to use biomarkers to guide and individualize the duration of antimicrobial therapy. This is of great importance for improving the quality of life of patients and ensuring treatment success, as well as for economic reasons for the healthcare system.

研究设计

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

入排标准

年龄范围
1 Month 至 99 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Immunosuppression will not be considered an exclusion criterion

排除标准

  • Patients who are not able to give their informed consent to participate in the study will be excluded

结局指标

主要结局

Diagnostic accuracy

时间窗: 01/01/2019 to 31/12/2022

Sensitivity, Specificity and predictive values

次要结局

未报告次要终点

研究者

发起方
Fundació Institut Germans Trias i Pujol
申办方类型
Other
责任方
Principal Investigator
主要研究者

Jose Antonio Dominguez Benitez

Senior Researcher

Fundació Institut Germans Trias i Pujol

研究点 (1)

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