NCT01380119已完成2 期
Phase 2 Study of Orally Formulated Heat-killed Mycobacterium Vaccae Study in TB Patients
Lisichansk Regional Tuberculosis Dispensary1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2011年8月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- sputum conversion
研究概览
简要总结
This is a phase II, randomized, placebo-controlled trial, aimed to seek the therapeutic benefit of V7 in combination with standard of care anti-Tuberculosis (TB) therapy (ATT) among Mycobacterium tuberculosis-infected sputum smear positive subjects. The results will be compared to placebo combined with standard ATT therapy. The trial will consist of one stage with sputum evaluation at months 1 and 2.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects who are at least 18 years old and are willing and capable of providing informed consent. Both men and non-pregnant women will be included.
- •TB infection documented prior to Study Entry by sputum smear positive for acid-fast bacilli (AFB) test.
- •TB score status at baseline.
- •Agreement to participate in the study and to give a sample of blood for lab testing.
- •Readily available home or other address where patient can be found.
排除标准
- •Subjects who might have already taken V5 in prior trial and have no baseline data. Pregnant or breast-feeding women are excluded.
- •Subjects who have taken study unrelated drugs or immunomodulatory therapies during study or prior to Entry.
- •Medical conditions such as active alcohol or substance abuse, or psychological issues that in the opinion of the local investigator would interfere with adherence to the requirements of this study.
结局指标
主要结局
sputum conversion
时间窗: 2 months
To compare the efficacy of combination of V7 with anti-TB treatment versus anti-TB treatment+placebo in adults with pulmonary tuberculosis including:
次要结局
- safety(1 and 2 months)
研究者
研究点 (1)
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