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
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- adherence
研究概览
简要总结
An open-label, randomised controlled trial comparing compliance to treatment for latent tuberculosis infection in socially marginalised citizens. Participants will be randomized to either daily isoniazid for 6 months or weekly rifapentine and isoniazid as directly observed therapy for twelve weeks.
详细描述
Eligible participants will be randomised to receive either daily isoniazid for 6 months with monthly visits for pill count, evaluation of adverse events and dispensing of isoniazid for the next month, or weekly doses of rifapentine and isoniazid for twelve weeks as direct observed therapy where the drugs are administered in the presence of a study nurse or doctor.
Control bloodsamples (ALAT, alkaline phosphatase, bilirubin, INR, haemoglobin, trombocytes and leukocyte differential count) will be taken at baseline and at least once during treatment in the rifapentine and isoniazid group and at least twice in the isoniazid-only group.
One year after treatment completion participants will be called in for evaluation for active tuberculosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
- •Porphyria
- •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
研究组 & 干预措施
RPT-INH
Participants treated with weekly rifapentine and isoniazid for twelve weeks.
干预措施: Rifapentine (Drug)
RPT-INH
Participants treated with weekly rifapentine and isoniazid for twelve weeks.
干预措施: Isoniazid (Drug)
control
Participants treated with daily isoniazid for six months
干预措施: Isoniazid (Drug)
结局指标
主要结局
adherence
时间窗: 2 years
adherence to treatment in the two groups measured by counting number of pills taken in each group.
次要结局
- active tuberculosis(5 years)
- adverse events(2 years)
研究者
Nina Breinholt Stærke
MD phd-student
Aarhus University Hospital