EUCTR2020-004084-10-Outside-EU/EEA进行中（未招募）1 期
Sequencing Mycobacteria and Algorithm-determined Resistant Tuberculosis Treatment; a pragmatic randomised controlled trial - SMARTT-trial
Flemisch Fund for Scientific Research - Fonds voor Wetenschappelijk Onderzoek0 个研究点开始时间: 2022年5月16日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •-Diagnosed with RR-TB on Xpert Ultra
- •Justification: The target population for the use of WGS if people with confirmed rifampicin resistant TB. Xpert Ultra is the initial test used for diagnosis of TB and RR-TB in South Africa.
- •-Diagnosed with pulmonary TB (PTB) or PTB plus extra-pulmonary TB (EPTB)
- •Justification: To assess the main outcome measure (time to culture conversion) weekly samples must be collected for Mtb culture. This is only possible in people with PTB.
- •-=18 years of age
- •Justification: collection of sputum samples in children is difficult and children most often have paucibacillary TB. We therefore propose to limit the study to adults with RR-TB.
- •-Able to sign informed consent
- •Justification: This is not an emergency research study. All people will thus need to complete the written informed consent process before any trial related procedure.
- •-Not on TB treatment at time of enrolment
- •Justification: There are two main reasons to limit enrolment to people not yet on TB treatment at time of enrolment: (1) In this phase IV pragmatic trial, we aim to study the use of WGS as this will most be implemented in routine care. We believe that WGS would be the first ‘reflex’ DST assay that will be performed after a RR-TB diagnosis. WGS would thus occur in people not yet on TB treatment, (2) On treatment, the myco-bacterial burden rapidly decreases, possibly reducing the success rate of WGS.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 248
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •-Patients diagnosed EPTB without pulmonary involvement
- •Justification: the primary endpoint of the trial is time to culture conversion. This requires collection of weekly samples for Mtb culture. This is not feasible and too burdensome for patients with EPTB without pulmonary TB as this would require weekly collection of an invasive sample.
- •-Patients with TB Meningitis or TB of the bone.
- •Justification: the treatment of patients with TB meningitis or TB of the bone is complicated and should always be decided by a exert committee. For optimal safety of these patients, they will be excluded from participation in this trial.
- •-Has any condition that, in the opinion of the investigator or physician, would preclude provision of informed consent, make participation in the study unsafe, complicate interpretation of study outcome data, interfere with achieving the study objectives or compromise patient safety.
- •Justification: this exclusion criteria aims to ensure optimal patient safety and scientific rigor.
研究者
相似试验
招募中
不适用
Sequencing Mycobacteria and Algorithm-determined Resistant Tuberculosis Treatment TrialRifampicin Resistant TuberculosisMultidrug Resistant TuberculosisPulmonary TuberculosesDrug-resistant TuberculosisNCT05017324Universiteit Antwerpen248
已完成
不适用
ext generation sequencing Microbiome analysis of respiratory tract using MetagenomicsDiseases of th respiratory systemKCT0003940Kyung Hee University Hospital20
已完成
不适用
ext generation sequencing Microbiome analysis of respiratory tract with Infection using MetagenomicsDiseases of th respiratory systemKCT0003943Kyung Hee University Hospital60
尚未招募
不适用
ext-Generation Sequencing diagnostics of bacteremia in Pediatric SepsisR65.1Systemic Inflammatory Response Syndrome of infectious origin with organ failureDRKS00015705Klinik für Anästhesiologie und Intensivmedizin, Universitätsklinikum Essen150
招募中
2 期
Finding the Optimal Regimen for Mycobacterium abscessus Treatment (FORMaT)Mycobacterium abscessus pulmonary diseaseMycobacterium abscessusRespiratory - Other respiratory disorders / diseasesHuman Genetics and Inherited Disorders - Cystic fibrosisInfection - Other infectious diseasesACTRN12618001831279The University of Queensland300