Maputo Tuberculosis Trial Unit- Project (MaTuTU- Project)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 81
- 试验地点
- 2
- 主要终点
- Number of participants with clinical and microbiological cure at month 6 after treatment initiation
研究概览
简要总结
In this longitudinal study with a follow up time of at least 6 months, up to 300 tuberculosis (TB) patients or TB suspects will be screened for TB using the Xpert MTB/RIF assay along with standard smear microscopy after Ziehl-Neelsen staining at the TB health clinic located at Mavalane health center. Confirmed TB cases will be followed up during TB therapy until month six after treatment initiation in order to obtain clinical and microbiological data on treatment including treatment response. Apart from relevant research questions in the field of TB diagnostics and treatment, the main objective of this study will be the development of a clinical TB research site, including capacity development in clinical and laboratory based TB research methods, in Mavalane, Maputo.
详细描述
Main study objective:
To assess the feasibility to perform a TB clinical trial in Maputo, Mozambique, by screening, examining,enrollment, follow-up and data collection of TB patients sent for TB treatment as well as TB suspects who are sent for smear microscopy to the TB clinic at the Mavalane health center.
Screening of study patients:
After consenting, each study participant (with confirmed or suspected TB) will be screened for TB with smear microscopy after Ziehl-Neelsen staining and Xpert MTB/RIF assay. In patients with signs of extrapulmonary TB manifestation, specimen collection other than sputum are to be decided by the treating physician in the patient' s best interest, to establish TB diagnosis by using smear microscopy and/or Xpert MTB/RIF assay. Patients without a positive Xpert MTB/RIF-assay result will not continue in the study but will be referred to the National TB Program for further evaluation and treatment. In patients with a positive Xpert MTB/RIF result in any specimen anti TB treatment will be commenced according to the National Guidelines. All TB positive study participants will be followed up until 6 months after TB treatment initiation.
Study methods:
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •>/= 18 years old
- •Able and willing to give informed consent to study participation, including HIV-testing
- •Positive TB result by Xpert MTB/RIF performed at the study clinic
排除标准
- •TB treatment in the last 6 months
- •Abandoned TB treatment at any time point in the past
- •Suffering from a condition likely to lead to uncooperative behaviour e.g. psychiatric illness or alcoholism.
- •Karnofsky index below 50%
结局指标
主要结局
Number of participants with clinical and microbiological cure at month 6 after treatment initiation
时间窗: 52 weeks in those patients which were enrolled until December 2014
次要结局
未报告次要终点
研究者
Michael Hoelscher
Prof. Dr.
Ludwig-Maximilians - University of Munich