Clinical Trial of Short Course vs. INH for LTBI in Jail

描述(申请人提供)：结核病(TB)在被监禁人口中是一个严重的问题，因为有很大比例的囚犯具有潜在的结核病感染(LTBI)和发展为活动性疾病的高风险。监狱中LTBI的完成治疗并不成功，主要是因为囚犯经常在完成每日异烟肼(INH)6-9个月的标准疗程之前获释，而且他们在社区完成治疗的比率很低。L脑外伤的有效治疗与治疗时间长短和药物的毒性有关。LTBI的短程疗法可能会解决这个问题，但它们还没有得到充分的研究，以回答有关副作用、完成率和总成本的问题。我们建议进行一项双臂开放标签随机试验，以测试短程治疗LTBI的效果；利福平每日服用4个月，与异烟肼每周两次治疗9个月的疗效相比。972名同意并登记的参与者将在监狱中接受直接观察疗法(DOT)。研究方案包括与结核病诊所的链接，以便在出院后进行DOT，并在整个治疗过程中密切监测临床和实验室。参与者将在监狱中和获释后，在登记后的一年内被跟踪调查，以衡量三个结果：毒性、依从性和成本效益。导致停药的毒性将由研究组分析，其他预测因素将被检查，如年龄、饮酒和乙肝和丙型肝炎。依从性将由研究组进行比较，其他预测因素将被检查，包括社会人口学变量、坚持的意图和住房的稳定性。成本效益将按研究小组进行比较，并将使用管理和监测护理的直接成本以及在重新逮捕率较高的人群中重新开始护理的成本来计算，以预防结核病病例的成本衡量。 短期疗程疗法在囚犯群体中治疗LTBI和消除进展为活动性疾病的风险是有希望的。这项研究将回答有关利福平与异烟肼的安全性问题。对该方案的完成情况和成本效果进行分析，将为L脑外伤监狱管理方式的政策变化提供重要信息。

DESCRIPTION (provided by applicant): Tuberculosis (TB) in incarcerated populations is a serious problem, due to the large proportion of inmates who are at high risk of having latent tuberculosis infection (LTBI) and developing active disease. Completion of treatment of LTBI has not been successful in jails, mainly because inmates are frequently released before finishing a 6-9 month course of standard therapy with daily isoniazid (INH), and because they have low rates of completing therapy in the community. Effective treatment of LTBI is complicated by length of therapy and toxicity of the drugs used against L TBI. Short-course therapies for LTBI may address this problem but they have not been studied adequately to answer questions about side effects, completion rates, and overall cost. We propose a two arm, open label randomized trial to test the effects of a short-course therapy for LTBI in jailed inmates; rifampin given daily for 4 months as compared to INH given twice weekly for 9 months. A sample of 972 consented and enrolled participants will be administered directly observed therapy (DOT) in jail. The study protocol includes links to the TB Clinic for post-release DOT, and close clinical and laboratory monitoring throughout the course of therapy. Participants will be followed, in jail and after release, for one year after enrollment, to measure three outcomes: toxicity, adherence, and cost-effectiveness. Toxicity leading to stopping drug will be analyzed by study group, and other predictors will be examined, such as age, alcohol use and hepatitis B and C. Adherence, measured by completion of therapy, will be compared by study group, and other predictors will be examined, including sociodemographic variables, intent to adhere, and stability of housing. Cost-effectiveness will be compared by study group and will be calculated using direct costs of administering and monitoring care and costs of re-starting care in this population with a high rate of re-arrest, measured against the cost of prevented cases of TB. Short course regimens are promising in the inmate population to treat LTBI and eliminate risk of progression to active disease. This study will answer questions about the safety of rifampin compared directly to INH. Analysis of completion of therapy and cost-effectiveness of this regimen will provide important information for policy change in the way L TBI is managed in jail.