A Study of Ultrashort PRS Regimen V in the Treatment of MDR-TB
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- patient cure rate
研究概览
简要总结
This is an exploratory, prospective, randomized, active control, and open label clinical trial to evaluate the efficacy and safety of 6-9 months treatment with the ultrashort PRS Regimen V.
详细描述
Shortening the course of treatment based on effective therapy can significantly improve patient compliance and reduce the public health burden.Research on optimal drug combination regimens to further shorten the duration and improve the efficacy of multidrug-resistant tuberculosis treatment is an important research direction.The PRS (parabolic response surface, FSC.II) system is an enhanced use of FSC to better identify and optimize optimal drug combinations.In preliminary studies, it was determined that PRS Regimens V （bedaquiline, delamanid, clofazimine, pyrazinamide）was superior to other regimens and would be a promising combination for XDR-TB because it does not contain fluoroquinolones or aminoglycosides. Preliminary trials have demonstrated that this regimen (PRS Regimens IV) can significantly reduce the duration of treatment required for MDR-TB and achieve a relapse-free cure.
Therefore, the investigators conducted an exploratory, prospective, randomized, positive-controlled, open, multicenter clinical study of this new regimen to observe the efficacy, safety, and recent relapse rate of the new regimen in the treatment of multidrug-resistant tuberculosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Untreated newly diagnosed patients with rifampicin resistant (RR) or multidrug resistant (MDR)-TB.
- •Newly treated patients: at least twice confirmed by molecular biology or phenotypic drug susceptibility test to have RR- or MDR-TB; Retreated patients: confirmed once by molecular biology or phenotypic drug susceptibility test to have RR- or MDR-TB.
- •Age between 18 and
- •No abnormality on EKG.
- •Able to understand and sign informed consent form.
排除标准
- •Presence of extrapulmonary TB (including tuberculous pleurisy);
- •History of allergic reaction to any of the drugs used in the study;
- •Presence of any of the following conditions that can lead to prolonged QT:
- •During screening process, ECG shows QT or QTc interval ≥ 450 ms (permit one non-prescheduled retest within the screening period to re-evaluate the testees' qualification);
- •Pathological Q waves (any Q wave duration of > 40 ms or depth > 0.4-0.5 mV);
- •Evidence of ventricular pre-excitation (such as Wolff-Parkinson-White Syndrome);
- •EKG shows evidence of complete or clinically significant incomplete left or right bundle branch block;
- •Evidence of 2nd or 3rd degree heart block;
- •Intraventricular conduction delay, QRS durations > 120 ms;
- •Slow heart rate, defined as sinus heart rate < 50 bpm;
- •Having personal or family history of long QT syndrome;
- •Having heart disease, symptomatic or asymptomatic arrhythmia, excluding sinus arrhythmia;
- •Fainting (i.e., cardiogenic fainting, not including vasovagal syncope or seizure)
- •Having risk factors for Torsade de pointes ventricular tachycardia (e.g. heart failure, hypokalemia, hypomagnesemia)
- •Pregnancy or liver, kidney, metabolic, autoimmunity, neurological, psychological or endocrine disease, blood system disease, malignant cancer, long-term users of immunosuppressant drugs.
- •Any patients, based on the judgement of the study medical researchers who are not suitable to participate in the trial or unlikely to complete the trial.
- •Participating in another clinical trial at the same time.
- •History of non-compliance in other clinical trials.
研究组 & 干预措施
Group A
Treatment according to WHO MDR-TB treatment guidelines (2019).
干预措施: MDR-TB Treatment Regimen(WHO) (Drug)
Group B(PRS Regimen V)
bedaquiline, delamanid, clofazimine, pyrazinamide
干预措施: PRS Regimen V (Drug)
结局指标
主要结局
patient cure rate
时间窗: Through study completion, an average of 18 months
Assessment of cure rate : 1. Cure. 2. Treatment completion. 3. Treatment failure. 4. Death. 5. Loss. 6. Inconclusive. 7. Treatment success.
次要结局
- Time to Cure by Primary Endpoint criteria(6-9 month)
- Time to culture positivity(Through study completion, an average of 18 months)
- Sputum conversion rate(Through study completion, an average of 18 months)
- Radiology changes(Through study completion, an average of 18 months)
- Relapse rate one and two years after treatment completion.(At 3, 6, 12, 18, and 24 months)
- Early bactericidal activity (EBA)(treatment initiation (Day 0; D0) and on Day 2 (D2), Day 7 (D7), and Day 14 (D14) after the start of treatment)
研究者
Wei Sha MD & PhD
Director, Head of Tuberculosis Department,Shanghai Pulmonary Hospital, Principal Investigator, Clinical Professor
Shanghai Pulmonary Hospital, Shanghai, China