Saliva and Dried Blood Spot Therapeutic Drug Monitoring for MDR-TB in Tanzania
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 51
- 试验地点
- 1
- 主要终点
- Drug exposure
研究概览
简要总结
Dried blood spot and saliva samples are collected during multidrug resistant tuberculosis (MDR-TB) treatment to measure the drug concentration of levofloxacin. Feasibility of both analytical procedures in a high burdened setting is explored.
详细描述
Background:
Measuring pharmacokinetic variability of anti-tuberculosis (TB) drugs and responding by dose correction will allow individualized treatment to improve microbiological response, curb acquired drug-resistance, protect and extend the efficacy of novel drugs rolled-out to endemic areas (pharmacovigilance), reduce toxicity to patients and lead to treatment duration shortening.
Aims and Objectives:
Implement Dried Blood Spot (DBS) collection for performance of high-performance liquid chromatography (HPLC) to optimize multidrug resistant TB (MDR-TB) treatment in Tanzania. Simultaneously, provide a proof-of-principle-demonstration that the developed saliva point of care drug assay for measurement of fluoroquinolone concentration works in a field setting.
Methods:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Participant is receiving care at Kibong'oto hospital
- •Age of 18 years or above
排除标准
- •Pregnancy at any gestation
- •Co-morbid conditions such as generalized severe ulcers, Kaposi sarcoma,
- •Hemophilia
- •Participants with medical conditions like malignancy, dementia or those who will be critically ill and unable to consent and provide DBS and Saliva.
- •Patients with Karnofsky score less than 40% or moribund
结局指标
主要结局
Drug exposure
时间窗: >2 weeks on treatment
Drug concentration (mgL)
次要结局
未报告次要终点
研究者
Jan-Willem C Alffenaar
prof
University Medical Center Groningen