Rifapentine-containing Treatment Shortening Regimens for Pulmonary Tuberculosis: A Randomized, Open-label, Controlled Phase 3 Clinical Trial. ACTG Study A5349
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 2,500
- 试验地点
- 2
- 主要终点
- TB disease free survival at twelve months after study treatment assignment
研究概览
简要总结
The purpose of this study is to determine whether one or two four-month regimens of tuberculosis treatment are as effective as a standard six-month regimen for treatment of pulmonary tuberculosis (TB). All three regimens are administered daily, seven days each week, with direct observation of each dose by a health-care worker at least five of the seven days of each week.
The standard six-month regimen is two months of isoniazid, rifampin, ethambutol, and pyrazinamide followed by four months of isoniazid and rifampin.
The first short regimen is a single substitution of rifapentine for rifampin: two months of isoniazid, rifapentine, ethambutol, and pyrazinamide, followed by two months of isoniazid and rifapentine.
The second short regimen is a double substitution of rifapentine for rifampin and moxifloxacin for ethambutol: two months of isoniazid, rifapentine, moxifloxacin, and pyrazinamide, followed by two months of isoniazid, rifapentine, and moxifloxacin.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Suspected pulmonary tuberculosis plus one or both of the following at least one sputum specimen positive for acid-fast bacilli on smear microscopy or at least one sputum specimen positive for M tuberculosis by Xpert MTB RIF testing with semiquantitative result of medium or high and rifamycin resistance not detected Age 18 years and older A verifiable address or residence location that is readily accessible for visiting and willingness to inform the study team of any change of address during the treatment and follow-up period Women of child bearing potential who are not surgically sterilized must agree to practice a barrier method of contraception or abstain from heterosexual intercourse during study drug treatment Documentation of HIV infection status For HIV-positive individuals CD4 T cell count greater than or equal to 100 cells per mm3 based on testing performed at or within 30 days prior to screening Karnofsky score greater than or equal to 60 Written informed consent.
排除标准
- •Pregnant or breast-feeding Unable to take oral medications Previously enrolled in this study Received any investigational drug in the past 3 months More than five days of treatment directed against active tuberculosis within 6 months preceding initiation of study drugs More than five days of systemic treatment with any one or more of the following drugs within 30 days preceding initiation of study drugs isoniazid rifampin rifabutin rifapentine ethambutol pyrazinamide kanamycin amikacin streptomycin capreomycin moxifloxacin levofloxacin gatifloxacin ofloxacin ciprofloxacin other fluoroquinolones ethionamide prothionamide cycloserine terizidone para-aminosalicylic acid linezolid clofazimine delamanid or bedaquiline Known history of prolonged QT syndrome Weight less than 40.0 kg Known allergy or intolerance to any of the study medications.
结局指标
主要结局
TB disease free survival at twelve months after study treatment assignment
时间窗: TB disease free survival at twelve months after study treatment assignment | Proportion of participants with grade 3 or higher adverse events during study drug treatment
Proportion of participants with grade 3 or higher adverse events during study drug treatment
时间窗: TB disease free survival at twelve months after study treatment assignment | Proportion of participants with grade 3 or higher adverse events during study drug treatment
次要结局
- TB disease-free survival at eighteen months after study treatment assignment(Time to stable sputum culture conversion)