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: 7559141
• 负责人: MARY Castle WHITE
• 金额: $ 45.91万
• 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 2009-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7559141
• 关键词: Address; Adherence; Adverse effects; Age; Alcohol consumption; Caring; Clinic; Clinical; Clinical Trials; Communities; Consent; Daily; Direct Costs; Directly Observed Therapy; Disease; Drug usage; Effectiveness of Interventions; Enrollment; Hepatitis B; Housing; Infection; Jail; Label; Laboratories; Length; Link; Measures; Monitor; Outcome; Participant; Persons; Pharmaceutical Preparations; Policies; Population; Prisoner; Protocols documentation; Randomized Controlled Clinical Trials; Rate; Rifampin; Risk; Safety; Sampling; Standards of Weights and Measures; Testing; Toxic effect; Treatment Protocols; Tuberculosis; Upper arm; cost; cost effectiveness; isoniazid; latent infection; prevent

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 LTBI. 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 LTBI is managed in jail.

结核病在监禁人口中是一个严重的问题，因为囚犯的比例很大 他们是潜伏性结核感染（LTBI）和发展为活动性疾病的高危人群。完成 长期创伤性脑损伤的治疗在监狱中并不成功，主要是因为囚犯经常被提前释放。 每天用异烟肼（INH）完成6-9个月的标准治疗， 在社区完成治疗。LTBI的有效治疗受到治疗时间的影响， 用于LTBI的药物的毒性。LTBI的短期疗法可能解决这个问题，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。 我们提出了一个两组，开放标签随机试验，以测试短期治疗LTBI的效果， 被监禁的囚犯;利福平每天给予4个月，而INH每周两次给予9个月。一 972例知情同意和入组的受试者样本将接受直接观察治疗（DOT）， 监狱该研究方案包括链接到结核病诊所后释放DOT，并密切临床和实验室 在整个治疗过程中进行监测。参与者将被跟踪，在监狱和释放后， 入组一年后，测量三个结果：毒性，依从性和成本效益。毒性 将按研究组分析导致停药的因素，并检查其他预测因素，如 年龄、酒精使用和B和C型肝炎。将比较通过完成治疗测量的依从性 将对研究组和其他预测因素进行检查，包括社会人口统计学变量， 附着力和稳定性。将按研究组比较并计算成本-效果 使用管理和监测护理的直接成本以及在这一人群中重新开始护理的成本， 与预防结核病病例的成本相比，再逮捕率很高。 短期治疗方案有望在囚犯人群中治疗LTBI并消除进展风险 到活动性疾病。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-效果分析将为临床提供重要信息， LTBI在监狱中管理方式的政策变化。

项目成果

Isoniazid vs. rifampin for latent tuberculosis infection in jail inmates: toxicity and adherence.

异烟肼与利福平治疗监狱囚犯潜伏性结核感染：毒性和依从性。

• DOI: 10.1177/1078345811435973
• 发表时间: 2012
• 期刊: Journal of correctional health care : the official journal of the National Commission on Correctional Health Care
• 作者: White,MaryC;Tulsky,JacquelineP;Lee,JuRuey-Jiuan;Chen,Lisa;Goldenson,Joe;Spetz,Joanne;Kawamura,LMasae
• 通讯作者: Kawamura,LMasae