PER-038-16招募中未知
Evaluating Newly Approved Drugs for Multidrug-resistant TB (endTB)
MEDICOS SIN FRONTERAS FRANCIA,0 个研究点目标入组 287 人开始时间: 2017年3月13日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- 入组人数
- 287
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •A patient will be eligible for randomization if s/he:
- •1.Has documented pulmonary tuberculosis due to strains of M. tuberculosis resistant to rifampin (RIF) and susceptible to fluoroquinolones, diagnosed by validated rapid molecular test;
- •2.Is ≥ 15 years of age ( Peru: >= 18 years of age);
- •3.Is willing to use effective contraception: pre-menopausal women or women whose last menstrual period was within the preceding year, who have not been sterilized must agree to use two methods of contraception (e.g., a hormonal method and a barrier method) unless their partner has had a vasectomy; men who have not had a vasectomy must agree to use condoms;
- •4.Provides informed consent for study participation; additionally a legal representative of patients considered minor per local laws should also provide consent;
- •5.Lives in a dwelling that can be located by study staff and expects to remain in the area for the duration of the study.
排除标准
- •1.Allergies or hypersensitivity to any of the investigational drugs;2.Pregnant or breast-feeding an infant3.No comply with treatment or follow-up schedule;4.condition which, in the opinion of the PI site´s,would make study participant unsafe;5.Exposure in the past five years, or resistance to, bedaquiline, delamanid, linezolid, or clofazimine.6.Has one ormore of thefollowing:•Hb≤7.9 g/dL;•Eelectrolytes disorders:Ca<7.0mg/dL;K<3.0or≥6.0mEq/L;Mg<0.9mEq/L;•Creatinine>3 x ULN•ASTorALT≥3xULN;•Total bilirubin ≥ 1.5xULN if accompanied by ASTorALT>ULNortotal bilirubin ≥ 2 x ULN when other liver function results are in the normal range;•Albumin<2.8g/dL;•Grade 4 result of the specified tests as defined byTheMSFSeverityScale.7.Cardiac risk factors:•Confirmed QTc interval of greater than or equal to 450 ms. Retesting to reassess eligibility will be allowed once using an unscheduled visit during the screening phase;•Ventricular pre-excitation;•Evidence of complete or clinically significant incomplete left bundle branch block or right bundle branch block;•Degreeheartblock;•Bradycardia sinus rate less than 50 bpm;•Personal or family history of Long QT Syndrome;•Arrhythmic cardiac disease, except sinus arrhythmia;•Syncope (i.e. not including syncope due to vasovagal or epileptic causes).8.Taking part in another trial of a medicinal product;9.medication that is contraindicated with the medicines in the trial regimen which cannot be stopped or requires a wash-out period longer than 2 weeks.10. Being infected with HIV
研究者
相似试验
进行中（未招募）
3 期
endTB-Q trials for Multidrug-Resistant TB with Fluoroquinolone Resistance.CTRI/2020/06/025618Medicins Sans Frontieres
已完成
3 期
endTB trials for Multidrug-Resistant TBCTRI/2020/07/026414Medicins Sans Frontieres31
招募中
不适用
EVALUATING NEWLY APPROVED DRUGS IN COMBINATION REGIMENS FOR MULTIDRUG-RESISTANT TB WITH FLUOROQUINOLONE RESISTANCE (Q)-A15 Respiratory tuberculosis, bacteriologically and histologically confirmedRespiratory tuberculosis, bacteriologically and histologically confirmedA15PER-020-20MEDICOS SIN FRONTERAS FRANCIA,
招募中
3 期
Evaluation of new drug treatments including artemisinin combination therapy for uncomplicated malaria in children in Papua New GuineaMalariaACTRN12605000550606niversity of Western Australia600
进行中（未招募）
1 期
Re-evaluation of Etilefrine and Diltiazem combined with Oseltamivir (Tamiflu) in the treatment of seasonal flu.EUCTR2016-004222-42-FRCentre Hospitalier Régional Universitaire de Lille264