A randomised controlled trial of a 12-dose rifapentine and isoniazid (RPT+INH) regimen using direct observed therapy (DOT) versus 6 months of daily isoniazid for latent tuberculosis infection (LTBI) in socially marginalised people

Dept of Infectious Diseases, Aarhus University Hospital0 个研究点目标入组 150 人开始时间: 2016年11月16日最近更新: 2022年3月2日

适应症

试验速览

暂无简介。

•Reporting to be homeless (independent of whether the person has an official address) or regularly seeking homeless shelters or public institutions to supply basic needs
•LTBI defined by positive IGRA test
•Found plausible by study doctor that the person has been exposed to tuberculosis within 2 years
•Aged 18 years or older
•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 150
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•Previously treated for tuberculosis
•Pregnant or breastfeeding
•Active tuberculosis (evaluated by chest x-ray and examination by a trained doctor)
•Unable to give informed consent
•Tested positive for LTBI as part of contact investigation where the index case has or is suspected to have INH of RIF resistant TB
•Known HIV on antiretroviral treatment
•Known allergy to rifamycins or isoniazid
•Known epilepsy
•Known liver disease causing affected liver parameters (ALAT, alkaline phosphatase, bilirubin, INR)
•Any lab abnormality, disease, concomitant medication or condition that, in the opinion of the investigator, excludes a person from participating

发起方

Dept of Infectious Diseases, Aarhus University Hospital