NCT05381194招募中4 期
The 6-month BPaL(M) Regimen for the Treatment of Patients With MDR/RR-TB: Multicenter, Single-arm, Operational Research, Clinical Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- A microbiological failure or clinical failure or relapse
研究概览
简要总结
The objective of this study is to analyze the efficacy of a new regimen using Bedaquiline, Pretomanid, Linezolid, and Moxifloxacin for 24 weeks or Bedaquiline, Pretomanid, Linezolid for 26 weeks for the treatment of MDR/RR-TB through the clinical trial.
详细描述
The BPaL (Bedaquiline, Pretomanid, Linezolid) regimen has been proven effective for the treatment of Fluoroquinolone-resistant MDR-TB through studies such as the NixTB and ZeNix trials. In addition, the BPaLM regimen has been demonstrated to have excellent efficacy in RR-TB patients through the TB-PRACTECAL study. This study aims to analyze the efficacy of the BPaL(M) regimen in Korean MDR/RR-TB patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At least 19 years old at enrolment
- •Bodyweight over 35Kg
- •If rifampicin resistance is confirmed through molecular or phenotypic drug susceptibility testing conducted on sputum or bronchoscopy specimens within 3 months of screening
- •Chest radiological findings consistent with pulmonary tuberculosis
排除标准
- •Uncontrolled DM
- •Extrapulmonary TB that would require treatment longer than would be usual for pulmonary TB
- •Less than 30 Karnofsky score at enrolment
- •BMI less than 17
- •Known severe allergy to any of the BPaLM regimen drugs
- •Medical history of Glucose-galactose malabsorption, galactose intolerance, and Lapp lactase deficiency
- •HIV-positive
- •The QTcF interval exceeds 450 msec on the electrocardiogram at baseline
- •Patients who are at risk of Torsade de Pointes due to underlying heart diseases such as heart failure or arrhythmia
- •For women of childbearing potential if the pregnancy test is positive, women who are breastfeeding or planning to become pregnant within 6 months of discontinuation/termination of treatment during the study, or who do not want contraception (i.e., oral and subcutaneous hormonal contraceptives, condoms, diaphragms, intrauterine device, or use of appropriate contraceptive methods including abstinence)
- •*Note: Double contraception (e.g., when a male uses a barrier contraceptive method such as a condom, a female partner uses a hormonal contraceptive or an additional contraceptive method such as an intrauterine device) is required while taking the study drug and up to 6 months after stopping/terminating the study drug. In particular, taking the study drug may affect the efficacy of hormonal contraceptives, and even if you are using only barrier contraception at the same time with your partner, you cannot be sure of preventing pregnancy, so it is necessary to maintain double contraception.
- •Men who plan to become pregnant during the study period or within 6 months of discontinuation/termination of treatment, or who do not wish to use double contraception or abstinence during this period.
- •Patients who have Grade 3 or 4 or higher peripheral neuritis, or Grade 1 or 2 with a high probability of progression to peripheral neuritis,
- •Current use of monoamine oxidase Inhibitor or used 2 weeks before treatment
- •Use of serotonergic antidepressant within 3 days of treatment
- •Any contraindication that may affect QTc interval (amiodarone, chloroquine, chlorpromazine, clarithromycin, haloperidol, etc.)
- •Any contraindication that may cause myelosuppression
- •Taking drugs that affect the cytochrome P450 enzyme within 30 days (quinidine, tyramine, ketoconazole, fluconazole, testosterone, quinine, gestodene, metyrapone, phenelzine, doxorubicin, troleandomycin, cyclobenzaprine, erythromycin, cocaine, furafylline, cimetidine, dextromethorphan, etc.)
- •Previously treated with Bedaquiline or Linezolid for more than 4 weeks
- •Abnormal value of a blood test at baseline:
- •Hypokalemia, Hemoglobin < 8.0 g/dL, Platelet < 75,000/mm3, ANC < 1000/mm3
- •AST or ALT > 3 X ULN, Total bilirubin >2.0 X ULN, Albumin < 3.2 mg/dL
- •Serum creatinine > 2 X ULN, Serum calcium < LLN, Serum magnesium < LLN
研究组 & 干预措施
single arm (investigational arm)
Experimental
BPaLM
干预措施: BPaL(M) regimen (Drug)
结局指标
主要结局
A microbiological failure or clinical failure or relapse
时间窗: until 12 months after the end of treatment
A microbiological failure or clinical failure or relapse during the treatment period and the 12-month follow-up period after end of treatment
次要结局
- Proportion of culture-negative patients at specific times (weeks 4, 8, 12, 16, and 24 or 26)(26 weeks or 24 weeks)
- All-cause mortality(26 weeks or 24 weeks)
- Time to sputum culture conversion during the treatment period(26 weeks or 24 weeks)
- Prescribed dose of Linezolid(26 weeks or 24 weeks)
研究者
Tae Sun Shim
Clinical professor, MD, PhD
Asan Medical Center
研究点 (1)
Loading locations...
相似试验
招募中
4 期
The Safety and Efficacy of BDL(Bedaquiline Plus Delamanid Plus Linezolid) Regimen in Subjects With Pulmonary Infection of Multi-drug Resistant Tuberculosis (MDR-TB) or Rifampicin-Resistant Tuberculosis (RR-TB)Pulmonary TuberculosisNCT06476210Beijing Chest Hospital45
已完成
2 期
A Study to Evaluate the Efficacy and Safety of Bedaquiline (TMC207) in Participants With Multibacillary LeprosyLeprosy, MultibacillaryNCT03384641Janssen Research & Development, LLC11
招募中
1 期
Phase 1 Clinical Trial of Lenvatinib, Pembrolizumab and Hypofractionated Pelvic Radiation Therapy for pMMR Recurrent/Unresectable Endometrial CarcinomaRecurrent Endometrial CarcinomaUnresectable Endometrial CarcinomaNCT05603910Aaron Wolfson18
招募中
4 期
A Study of an Oral Short-course Regimen Including Bedaquiline for the Treatment of Participants With Multidrug-resistant Tuberculosis in ChinaTuberculosis, Multidrug-ResistantNCT05306223Beijing Chest Hospital212
尚未招募
4 期
Clinical Study of New Intensive Treatment Regimen for Severe Nontuberculous Mycobacterial Pulmonary DiseaseNontuberculous Mycobacterial Lung DiseaseNCT05494957Shanghai Pulmonary Hospital, Shanghai, China40