NCT00567840已完成2 期
A Phase IIa Trial to Evaluate the Safety, Tolerability, Extended Early Bactericidal Activity and Pharmacokinetics of 14 Days' Treatment With Four Oral Doses of PA-824 in Adult Participants With Newly Diagnosed, Uncomplicated, Smear-Positive, Pulmonary Tuberculosis
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 69
- 试验地点
- 2
- 主要终点
- Early Bactericidal Activity (EBA) Measured as the Daily Rate of Change in log10 CFUs (Colony Forming Units) of M. Tuberculosis in Sputum on Solid Media (Days 0-14).
研究概览
简要总结
The trial will evaluate the extended bactericidal activity of 14 consecutive days of oral administration of PA-824 at 200, 600, 1000 and 1200 mg per day in adult patients with newly diagnosed, uncomplicated, smear positive tuberculosis. A control group will receive standard TB treatment.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •informed consent
- •M/F 18-64 yo
- •newly diagnosed pulmonary TB
- •sputum positive
- •adequate contraception
排除标准
- •poor health
- •rifampicin resistance
- •treatment with other anti TB agents in last 3 mos.
- •extrapulmonary TB
- •neuropathy
- •ECG wih QRS prolongation ove 120 msec
- •CV disorder
- •diabetes requiring insulin
- •Metabolic disease
- •drug/alcohol abuse
- •pregnancy
- •use of substances that are strong inhibitors/inducers of CYP450
- •use of ARV
研究组 & 干预措施
3
Experimental
PA-824 1000 mg/qd
干预措施: PA-824 (Drug)
4
Experimental
PA-824 1200 mg/qd
干预措施: PA-824 (Drug)
1
Experimental
PA-824 200 mg/qd
干预措施: PA-824 (Drug)
2
Experimental
PA-824 600 mg/qd
干预措施: PA-824 (Drug)
5
Active Comparator
Rifafour e-275 mg
干预措施: PA-824 (Drug)
结局指标
主要结局
Early Bactericidal Activity (EBA) Measured as the Daily Rate of Change in log10 CFUs (Colony Forming Units) of M. Tuberculosis in Sputum on Solid Media (Days 0-14).
时间窗: Day 0 and Day 14
次要结局
- Early Bactericidal Activity (EBA) Measured as the Daily Rate of Change in log10 CFUs (Colony Forming Units) of M. Tuberculosis in Sputum on Solid Media (Days 0-2).(Day 0 and Day 2)
- Early Bactericidal Activity (EBA) Measured as the Daily Rate of Change in log10 CFUs (Colony Forming Units) of M. Tuberculosis in Sputum on Solid Media (Days 2-14).(Day 2 and Day 14)
- EBA Expressed as the Change in Time to Positive (TTP) Signal in Liquid Culture for M. Tuberculosis (Days 0-14)(Day 0 and Day 14)
- EBA Expressed as the Change in Time to Positive (TTP) Signal in Liquid Culture for M. Tuberculosis (Days 0-2)(Day 0 and Day 2)
- EBA Expressed as the Change in Time to Positive (TTP) Signal in Liquid Culture for M. Tuberculosis (Days 2-14) Show Description: [Not Specified](Day 2 and Day 14)
研究者
研究点 (2)
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