患者的早期访问TMC207广泛耐药或Pre-XDR肺结核

TMC207正在调查治疗结核病。结核病是一种由结核分枝杆菌引起的传染性细菌感染通常影响到肺,但也可以影响其他器官。治疗结核病是漫长和繁琐,进一步复杂化耐多药结核分枝杆菌菌株的出现。TMC207是diarylquinoline临床实验的抗结核作用的化合物提供了一个新颖的机制专门抑制分枝杆菌三磷酸腺苷(ATP)合成酶。耐多药结核病(mdr - TB)的定义是感染的结核分枝杆菌的一种耐异烟肼和RMP(也称为利福平),两个重要的药物用于治疗药物敏感结核病。广泛耐药结核病(xdr - TB)被定义为耐多药结核病与附加阻力最重要的二线抗结核药物,即一个注射剂(卡那霉素、阿米卡星、或卷曲霉素)和氟喹诺酮类原料药。Pre-XDR结核病被定义为耐多药结核病与附加阻力FQ或注射(卡那霉素、阿米卡星、或卷曲霉素),但不要FQ和注射。或广泛耐药结核患者pre-XDR将被包含在这个早期访问研究。病人有资格获得这项研究将提供一个24周的TMC207将管理方案(BR)连同他们的背景。BR药物将由现场调查员提供或指定的研究人员依照国家结核病项目(国家结核控制规划)的指导方针。 The BR should be constructed with at least 3 anti-tuberculosis drugs to which the patient's infection is known to be susceptible from recent drug susceptibility testing (DST) results (within the previous 6 months) or likely to be susceptible, based on known treatment history. The selection of the BR, including the number of companion drugs for TMC207, will be the responsibility of the investigator. At the screening visit, a completed inclusion/exclusion checklist list will be sent to the sponsor or its representative together with the patient's recent smear or culture and DST results (within preceding 6 months) and laboratory safety results to confirm eligibility. At baseline, a chest X-ray (CXR) will be taken in case no CXR or results of other imaging of the lungs are available within the previous month. Once treatment has been initiated, patients will be instructed to follow the visit schedule based on routine clinical care. Recommended visits and assessments should be planned 2, 4, 12, and 24 weeks following initiation of TMC207 in combination with the BR and 4 weeks (Week 28) and every 24 weeks (Weeks 48, 72, 96, and 120) after completion of TMC207 intake during the 96-week follow-up period. If needed, extra visits and assessments can be planned at the discretion of the investigator in order to best manage the patient's TB treatment. Patients who are taking clofazimine with TMC207 will require electrocardiogram (ECG) monitoring at mandatory protocol-specified visits. Serum chemistry (electrolytes) assessment will be performed at every visit in which an ECG is performed. After their last intake of TMC207, all patients will continue to take their BR under the supervision of their treating physician or local health center/hospital in accordance with NTP guidelines and local multi-drug resistant (MDR) TB treatment practice (i.e., treatment may be extended for reasons of complicated lung disease, etc.). Patients will be followed up for 96 weeks (2 years) after their last dose of TMC207 to evaluate the microbiological effect (verification of microbiological status [measured locally as per local standard of care; eg, smear, culture, DST] is recommended to be performed every 24 weeks) that TMC207 has provided these patients, as well as to monitor the safety and tolerability of TMC207. Patients who withdraw early, unless due to withdrawal of informed consent, will be followed for survival/clinical outcome (approximately every 6 months) until the early access study comes to an end in the patients' corresponding country. Patients can enter the study until TMC207 will be commercially available in the patient's country or can be accessed from another source or until discontinuation of the development program of TMC207.