EUCTR2015-003446-45-ES进行中（未招募）不适用
Rifapentine-containing treatment shortening regimens for pulmonary tuberculosis: A randomized, open-label, controlled phase 3 clinical trial - TBTCS31
nidad de investigación en Tuberculosis de Barcelona0 个研究点目标入组 2,500 人开始时间: 2015年10月15日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 2,500
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •A.Suspected pulmonary tuberculosis plus one or both of the following: a) at least one sputum specimen positive for acid-fast bacilli on smear microscopy OR b) 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.
- •B.Age twelve (12) years or older
- •C.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.
- •D.Women of child-bearing potential who are not surgically sterilized must agree to practice an adequate method of contraception (barrier method or non-hormonal intrauterine device) or abstain from heterosexual intercourse during study drug treatment.
- •E.Documentation of HIV infection status.
- •F.For HIV-positive individuals, CD4 T cell count greater than or equal to 100 cells/mm3 based on testing performed at or within 30 days prior to study entry. HIV-positive individuals will be enrolled in a staged approach as described in Section 8.3.10.1, specifically:
- •?Group 1 (?EFV1?): receipt of efavirenz-based antiretroviral therapy (ART) for a minimum of 30 days at the time of enrollment AND a documented HIV viral load less than 200 copies/mL at or within 30 days prior to study entry, OR
- •?Group 2 (?EFV2?): for HIV-positive individuals not on ART at enrollment, planned initiation of efavirenz-based ART before or at study week 8
- •G.Laboratory parameters done at or within 14 days prior to screening:
- •?Serum or plasma alanine aminotransferase (ALT) less than or equal to 3 times the upper limit of normal
- •?Serum or plasma total bilirubin less than or equal to 2.5 times the upper limit of normal
- •?Serum or plasma creatinine level less than or equal to 2 times the upper limit of normal
- •?Serum or plasma potassium level greater than or equal to 3.5 meq/L
- •?Hemoglobin level of 7.0 g/dL or greater
- •?Platelet count of 100,000/mm3 or greater
- •H.For all women who are not surgically sterilized or who do not meet the study definition of post-menopausal, a negative pregnancy test at or within seven (7) days prior to screening
- •I.Karnofsky score greater than or equal to 60
- •J.Written informed consent
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 100
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 2000
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 400
排除标准
- •A.Pregnant or breast-feeding
- •B.Unable to take oral medications
- •C.Previously enrolled in this study
- •D.Received any investigational drug in the past 3 months
- •E.More than five (5) days of treatment directed against active tuberculosis within 6 months preceding initiation of study drugs
- •F.More than five (5) 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
- •G.Known history of prolonged QT syndrome
- •H.Suspected or documented tuberculosis involving the central nervous system and/or bones and/or joints, and/or miliary tuberculosis and/or pericardial tuberculosis
- •I.Current or planned use within six months following enrollment of one or more of the following medications: HIV protease inhibitors, HIV integrase inhibitors, HIV entry and fusion inhibitors, HIV non-nucleoside reverse transcriptase inhibitors other than efavirenz; quinidine, procainamide, amiodarone, sotalol, disopyramide, ziprasidone, or terfenadine.
- •J.Weight less than 40.0 kg
- •K.Known allergy or intolerance to any of the study medications
- •L.Individuals will be excluded from enrollment if, at the time of enrollment, their M. tuberculosis isolate is already known to be resistant to any one or more of the following: rifampin, isoniazid, pyrazinamide, ethambutol, or fluoroquinolones.
- •M.Other medical conditions, that, in the investigator?s judgment, make study participation not in the individual?s best interest.
- •N.Current or planned incarceration or other involuntary detention.
研究者
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