The Influence of Fasting and Food on the Pharmacokinetics of Isoniazid, Rifampicin, Pyrazinamide, and Ethambutol in Newly Diagnosed TB Patients
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- pharmacokinetics
研究概览
简要总结
WHO recommends to take TB drugs while fasting: if TB drugs are taken with food, perhaps drug concentrations are too low; on the other hand: if this is not tolerated, drugs could also be taken with food.
Do lower drug concentrations - with improved adherence to therapy - outweigh the disadvantage of lower drug blood concentrations over time? How exactly do the drug concentrations over time (pharmacokinetics) compare between fasting and fed conditions, especially in the early stage of TB treatment when patients are relatively sick, and relatively poorly tolerate TB drugs?
详细描述
To evaluate the influence of concomitant food ingestion on the pharmacokinetics of HRZE in newly diagnosed TB patients To evaluate the influence of early disease on the PK parameters of HRZE in TB patients To compare the pharmacokinetics of HRZE in the early stage of disease with the pharmacokinetics of HRZE in more stable condition in newly diagnosed TB patients To evaluate adverse events of HRZE in TB patients
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
- 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
- •Patients with TB who are starting with HRZE therapy
- •Age > 18 years old
- •Written informed consent
排除标准
- •Use of antacids, which cannot be discontinued for study days
- •Active, unstable hepatic disease (with jaundice, HRZ)
研究组 & 干预措施
Fasting-Fed
blood sampling on 3 consecutive days; by randomization, drug treatment as follows: day 1, HRZE as iv therapy; on day 2, HRZE as oral therapy in fasting condition (2 hours before meals); and on day 3 HRZE as oral therapy in fed condition (after meals).
干预措施: intravenous administration of 1st line TB drugs, day 1 (Drug)
Fed-Fasting
blood sampling on 3 consecutive days; by randomization, drug treatment as follows: day 1, HRZE therapy as iv therapy; day 2, HRZE as oral therapy in fed condition, and on day 3, HRZE as oral therapy in fasting condition
干预措施: intravenous administration of 1st line TB drugs, day 1 (Drug)
结局指标
主要结局
pharmacokinetics
时间窗: 3 days - week 1 and week 8
pharmacokinetics (AUC0-8, Cmax, and Tmax); comparison between TB patients who take HRZE concomitant with food and TB patients who take HRZE concomitant without food, weeks 1 and 8 of treatment
pharmacokinetics (AUC0-8, Cmax, and Tmax) of HRZE
时间窗: 11 time points, 3 consecutive days - wk 1 & 8
PK curves from venous blood specimens sampled from indwelling venous catheter
次要结局
- To evaluate adverse events of HRZE, week 1 and 8 - while taking food or not(week 1 - week 8)
研究者
Tjip van der Werf
Professor, Infectious Diseases & Tuberculosis
University Medical Center Groningen