EUCTR2016-000850-36-NL进行中（未招募）1 期
Double-Blind, Randomized, Placebo-Controlled Phase IIa Clinical Trial to Investigate the Safety and Immunogenicity of RUTI® Therapeutic Vaccination in Patients with Multi-Drug Resistant Tuberculosis after successful intensive-phase treatment. - Safety of RUTI® vaccine in MDR-TB
Archivel Farma S.L.0 个研究点目标入组 27 人开始时间: 2016年10月25日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 27
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
- •Female or Male patients (aged > 18)
- •- diagnosed with active MDR-TB
- •- having successfully completed 16 (Cohort A) or 12 weeks (Cohort B) of MDR-TB treatment fully supervised with beneficial initial response to therapy, evidenced by
- •i) Clinical response criteria (reduction of weight loss, chronic cough, fever, or night sweats) and
- •ii) Microbiological response criteria (improvement in at least two measurements at least 4 weeks apart using Mycobacterial Growth Indicator Tube (MGIT, also known as liquid culture)), and
- •iii) Radiological response criteria (Chest X-Ray)
- •- The patient must provide written informed consent
- •- The patient must be willing and able to attend all study visits and comply with all study procedures
- •- Females of childbearing potential must have a negative pregnancy test at enrolment and must agree to use highly effective methods of birth control during and 30 days after the study
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 27
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Inability to provide written informed consent
- •Women reported, or detected, or willing to be pregnant during the trial period;
- •Severity of illness precluding full evaluation: expected early death, evidenced by respiratory failure, low blood pressure, WHO performance score 3-4; Central Nervous System involvement of TB (TB meningitis, intra-cranial tuberculomas) as there is too little evidence for effective drug penetration for second-line TB drugs;
- •Major co-morbid conditions precluding full evaluation, i.e., active lung cancer, acute coronary syndrome, heart failure exceeding NYHA class 2; a diagnosis of metastasized malignancy; renal failure in excess of creatinine clearance < 30 mls/min calculated by the Cockcroft-Gault formula, which would severely complicate administration of aminoglycosides and capreomycin, considered as the major second-line TB drugs; obesity (BMI>30 kg/m2); chronic liver disease – Child-Pugh class C;
- •Any of the following laboratory parameters:
- •oAspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 3 x upper limit of normal (ULN)
- •ototal bilirubine > 2 x ULN
- •oNeutrophil count = 500 neutrophils / mm3
- •oPlatelet count < 50,000 cells / mm3
- •Receiving or anticipated to receive a daily dose of = 10 mg of systemic prednisone or equivalent within the period starting 14 days prior to enrolment. Note: patients are allowed to receive an acute, short course of methylprednisolone or prednisone or equivalent for management of an acute exacerbation of COPD or reactive airway disease in asthmatics
- •Cytotoxic chemotherapy or radiation therapy within the previous 3 months
- •HIV co-infection, if CD4 count < 350 copies/mL; those with 350 copies/mL are expected to be able to mount a sufficient cellular immune response and will therefore be eligible
- •Blood transfusion in the last three weeks prior to the trial
- •Documented allergy to TB vaccines, notably, to the RUTI® vaccine.
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