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

短期疗程与 INH 治疗监狱 LTBI 的临床试验

• 批准号: 6803175
• 负责人: MARY Castle WHITE
• 金额: $ 73.81万
• 依托单位: UNIVERSITY OF CALIFORNIA, SAN FRANCISCO
• 依托单位国家: 美国
• 财政年份: 2003
• 资助国家: 美国
• 起止时间: 2003-09-30 至 2007-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6803175
• 关键词: Mycobacterium tuberculosis; age difference; alcoholism /alcohol abuse; clinical research; clinical trial phase III; cooperative study; correctional institutions; cost effectiveness; drug administration rate /duration; drug adverse effect; hepatitis B; hepatitis C; housing; human subject; human therapy evaluation; isoniazid; microorganism disease chemotherapy; patient oriented research; residential mobility; rifamycins; socioeconomics; therapy compliance; tuberculosis

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.

描述（由申请人提供）：结核病（TB）在监禁人口中是一个严重的问题，因为大部分囚犯都处于潜伏性结核病感染（LTBI）和发展活动性疾病的高风险之中。在监狱中完成长期创伤性脑损伤的治疗并不成功，主要是因为囚犯经常在完成6-9个月的每日异烟肼标准治疗之前就被释放，还因为他们在社区中完成治疗的比例很低。LTBI的有效治疗因治疗时间长度和针对LTBI使用的药物的毒性而复杂化。LTBI的短期治疗可能会解决这个问题，但尚未进行充分的研究来回答有关副作用，完成率和总成本的问题。 我们提出了一个两个手臂，开放标签随机试验，以测试短期治疗的LTBI在被监禁的囚犯，利福平每天给予4个月相比，INH每周两次，9个月的效果。972名同意和登记的参与者将在监狱中接受直接观察治疗（DOT）。该研究方案包括与TB诊所的链接，用于释放后DOT，以及整个治疗过程中的密切临床和实验室监测。参与者将被跟踪，在监狱和释放后，在登记后一年，以衡量三个结果：毒性，依从性和成本效益。将按研究组分析导致停药的毒性，并检查其他预测因素，如年龄、饮酒和B和C型肝炎。通过完成治疗来衡量的依从性将按研究组进行比较，并将检查其他预测因素，包括社会人口统计学变量、依从意图和住房稳定性。成本效益将按研究组进行比较，并将使用管理和监测护理的直接成本以及重新开始护理的成本（针对预防结核病病例的成本）计算。 短期治疗方案在囚犯人群中治疗LTBI和消除进展为活动性疾病的风险是有希望的。本研究将回答有关利福平与INH直接比较的安全性问题。对该方案的治疗完成情况和成本效益的分析将为监狱管理L TBI的政策变化提供重要信息。