Rifapentine-containing Treatment Shortening Regimens for Pulmonary Tuberculosis: A Randomized, Open-label, Controlled Phase 3 Clinical Trial. ACTG Study A5349 - A5349

The Centers for Disease Control and Prevention0 个研究点目标入组 0 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•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

•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

发起方

The Centers for Disease Control and Prevention