Research to Improve the Detection and Treatment of Latent Tuberculosis Infection: Diagnostics (RID-TB:Dx)A randomised controlled trial to evaluate the effectiveness of using the RD-1 based C Tb skin test as a replacement for blood-based interferon-? release assay for detection of latent TB infection and initiation of TB preventive treatment in the UK - RID-TB:Dx

niversity College London0 个研究点目标入组 1,705 人开始时间: 2020年2月10日最近更新: 2020年9月21日

试验速览

暂无简介。

•1. Age =16 years
•2. Eligible for LTBI testing with IGRA and treatment for LTBI according to UK guidance
•3. Willing and able to provide written informed consent
•4. Willing and able to comply with the trial, including the randomised test(s) and adherence to follow up visits
•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 1705
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range 0

•1. Allergy to C-Tb product or any of its constituents
•2. Displaying any symptoms or signs of active TB disease:
•Unexplained fever; Cough (more than three weeks); Haemoptysis (Blood in sputum); Unexplained weight loss; Drenching night sweats; Lymph node swelling
•3. Women who are breastfeeding, pregnant or plan to become pregnant during the study
•Women of childbearing potential not using contraception
•A woman of child bearing potential (WOCBP): 12 years of age or older having had their first menstruation and until becoming post-menopausal unless permanently sterile. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause.
•Effective contraception includes barrier (including spermicidal gel), hormonal or intrauterine contraceptive measures within the trial period

发起方

niversity College London