EUCTR2020-004444-29-GB进行中（未招募）1 期
An open-label, multi-centre, randomised controlled trial evaluating the effects of short-course rifapentine-based regimens and additional adherence support on LTBI treatment adherence and completion among adults in the UK - RID-TB:Treat
niversity College London0 个研究点目标入组 920 人开始时间: 2020年9月17日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 920
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
- •1.Aged =16 years to =65 at screening
- •2.LTBI diagnosis defined on the basis of all of the following:
- •(a)a positive result on an Interferon Gamma Release Assay (IGRA), Tuberculin Skin Test (TST) or C-Tb skin test and
- •(b)negative TB symptoms at screening and
- •(c)no signs of active TB on a Chest X-ray
- •3.Eligible for LTBI treatment at TB clinics and national LTBI screening services based on NICE guidelines, which means having one or more of the following :
- •Recent infection (contact tracing);
- •New entrants at risk (i.e., those that immigrated < 5 years from countries with a high incidence of TB, which is defined as = 40 cases/100,000 population); or
- •Individuals who are assessed in the TB clinic for latent TB testing, or have been referred for treatment following testing by specialities or departments within primary or secondary care settings
- •4.Agree to LTBI treatment
- •5.Willing and able to provide written informed consent
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 900
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •1.Patients weighing < 30 kg.
- •2.Need for medications that cannot be safely taken together with study drugs
- •3.Any medical condition deserving priority of treatment (such as: porphyria, malabsorption syndromes, Clostridium difficile-Associated Diarrhoea and other conditions)
- •4.History of sensitivity/intolerance to isoniazid or rifamycins
- •5.Individuals with documented liver disease, defined as:
- •LFT (ALT/AST/bilirubin) over three times upper limit of normal (ULN) at baseline. This reflects normal clinical practice. For patientparticipant safety, liver function tests are carried on a regular basis. One abnormal value prevents the patient from participating on the study.
- •Clinical diagnosis of cirrhosis (jaundice, hematemesis, ascites or previous episodes of liver encephalopathy),
- •HbsAg positive or HCV antibody positive and deemed ineligible for LTBI treatment by the clinician
- •6.Intending to move outside of the treatment locality within 20 weeks of starting treatment
- •7.Individuals who would usually be offered LTBI treatment under Directly Observed Therapy (DOT) as part of enhanced case management in complex cases such as those from under-served groups (such as people who are homeless, misuse substances, have been in prison or who are vulnerable migrants).
- •8.Use of another experimental investigational medicinal product that is likely to interfere with the study medication within 3 months of study enrolment.
- •9.Women who are breastfeeding, pregnant, or of childbearing potential* who do not agree to use an effective method of contraception from the time consent is signed until 4 weeks after treatment discontinuation or completion.
- •10.Women of child bearing potential without a negative urine pregnancy test within 7 days prior to being registered for trial treatment.
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