Double-blind, Randomized, Masked, Placebo-controlled, Clinical Trial to Investigate the Efficacy of the Nutraceutical Nyaditum Resae(R) Administered to Contacts of Active Tuberculosis in Georgia.
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 3,300
- 试验地点
- 1
- 主要终点
- Efficacy, incidence of confirmed cases of active TB
研究概览
简要总结
The use of a supplement food like "Nyaditum resae" is a reliable opportunity to stop the progression towards active TB through the most updated knowledge of this disease:the induction of tolerance.
In order to demonstrate the percentage of efficacy of this approach, different studies must be run to elucidate the percentage of protection in different setting all over the world. The strategy is to establish its efficacy through a simple clinical trial, aimed just to know the incidence of TB in Placebo and NR treated contacts of active TB cases.
详细描述
Evaluation of a supplement food "Nyaditum resae" in the uincidence of TB. This is a ranzomized doube-blind controlled clinical trial to evaluate the efficacy and safety of a supplememt food in comparison to placebo in TB.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 5 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Have completed the written informed consent process prior to undergoing any screening evaluations.
- •Have ability to complete follow-up period as required by the protocol.
- •Willing to allow the investigators to discuss the subject's medical history with the subject's health care provider.
- •Close contact of an active TB case not eligible for chemoprophylaxis.
排除标准
- •Investigator assessment of lack of understanding or willingness to participate and comply with all requirements of the trial protocol.
- •Any other finding which in the opinion of the investigator would compromise the protocol compliance or significantly influence the interpretation of results on the effects of the vaccine.
- •Being eligible for chemoprophylaxis (children of <5 years old and HIV-positive adults)
- •Pregnancy or lactation
- •Hypersensitivity to mannitol
- •Suffering active TB
研究组 & 干预措施
Placebo
Subjects will receive a total of 14 capsules with Placebo
干预措施: Placebo (Biological)
Nyaditum resae(R)
Subjects will receive a total of 14 capsules with Nyaditum resae(R)
干预措施: Nyaditum resae(R) (Biological)
结局指标
主要结局
Efficacy, incidence of confirmed cases of active TB
时间窗: 2 years
The primary endpoint is to assess the incidence of active TB: confirmed TB cases (including extrapulmonary TB) as described as: Clinical, radiology or histology evidence compatible with active TB plus validated Molecular Biology tests POSITIVE, or culture POSITIVE. The GeneXpert MTB/RIF system will be used as molecular diagnostic test to identify M. tuberculosis in this trial. Although this, in case a patient is diagnosed using any other validated method (i.e.: diagnosed in a site not participating in the trial), this could be accepted if well documented Cultures will be done using validated methodologies, including both solid and liquid cultures. An independent Endpoint Committee will be created to confirm all the TB cases.
次要结局
- Incidence of adverse events during the administration of the NR(2 weeks)
- Efficacy, incidence of all cases of active TB and mortality (all causes)(2 years)