2024-518772-32-00招募中2 期
A randomised, prospective phase II study of pharmacokinetics and safety aspects of higher doses of rifampicin and pyrazinamide in a shortened treatment of mild-to-moderate tuberculosis compared with standard of care
Region Oestergoetland2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年10月18日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- The primary variable is the area under concentration and time curve (AUC0-24h) for high-dose RIF in a combination regimen with high-dose PZA on day 1 after the first dose and at week 2.
研究概览
简要总结
The main aim of the study is to investigate strategies for reducing the length of TB treatment through detailed study of a shorter TB treatment based on higher doses of RIF and PZA, for a selected group of patients with drug-sensitive pulmonary TB.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Confirmed active pulmonary tuberculosis, through positive culture or positive PCR test for M.tuberculosis-complex.
- •Has provided written consent
- •Assigned for TB-treatment (first-line drugs) but not yet started treatment
排除标准
- •Has received treatment for active TB in the past 12 months leading up to inclusion in the study
- •Resistance to any of the drugs (RIF, INH, PZA, EMB) included in the standard TB treatment according to molecular biological or phenotypic drug susceptibility testing.
结局指标
主要结局
The primary variable is the area under concentration and time curve (AUC0-24h) for high-dose RIF in a combination regimen with high-dose PZA on day 1 after the first dose and at week 2.
The primary variable is the area under concentration and time curve (AUC0-24h) for high-dose RIF in a combination regimen with high-dose PZA on day 1 after the first dose and at week 2.
次要结局
未报告次要终点
研究者
Katarina Niward
Scientific
Region Oestergoetland
研究点 (2)
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