The Role of Therapeutic Drug Monitoring in Tuberculosis - a Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 38
- 试验地点
- 2
- 主要终点
- Rifampicin concentration in relationship to MIC over 10
研究概览
简要总结
Drug resistant TB is increasing and in order to enchance the efficacy of the current drugs, individualized therapy using plasma drug concentrations and minimal inhibitory concentration (MIC) determination may be of importance. This concept is defined as therapeutic drug monitoring (TDM).
In this pilot study our hypothesis is that the ratio between MIC and drug concentration data is correlated to the bacterial load measured as time to positive liquid culture (TTP).
In two sites in Sweden (Linköping and Karolinska Hospital Solna, Stockholm), 25 patients with pulmonary tuberculosis will be recruited. MIC-determination of Mycobacterium tuberculosis will be performed in BACTEC 960 MGIT and drug concentration will be determined at 2, 4 and 12 weeks after treatment initiation using LC-MS/MS methodology. Sputum cultures will be obtained at 0, 2 days, 7 days, 2 weeks, 4 weeks and 8 weeks and TTP will be measured in duplicate samples. Clinical follow up according to WHO criteria will be performed 1 year after completion of treatment.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •Age>18 years, culture verified tuberculosis
排除标准
- •Other infectious diseases other than HIV or tuberculosis
结局指标
主要结局
Rifampicin concentration in relationship to MIC over 10
时间窗: 2 weeks
次要结局
- Cure rate on Clinical follow up (according to WHO criteria) in relation to rifampicin concentration at week 2(1 year)
- Sputum Culture conversion in relation to rifampicin, isoniazid and pyrazinamid concentration week 2(2 and 8 weeks)
- TB-score in relation to rifampicin, isoniazid and pyrazinamid concentration week 2(8 weeks)
- Time to positive Culture (TTP) in relation to isoniazid, ethambutol and pyrazinamid serum concentration and minimal inhibitory concentration (MIC)(2 and 8 weeks)
- Time to positive Culture (TTP) in relation to rifampicin serum concentration and minimal inhibitory concentration (MIC)(2weeks)
研究者
Thomas Schon
MD PhD
Linkoeping University