NL-OMON56472尚未招募不适用
A phase I study investigating local tolerability and pharmacokinetics of Isoniazid (INH) inhalation by wet nebulization in patients with tuberculosis - INHalation-01
Rijksuniversiteit Groningen0 个研究点目标入组 8 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 8
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •- Age 18 years and older
- •- Diagnosis of TB with known drug susceptibility, either by culture or
- •molecular testing
- •- Clinically stable or improving after at least 2 weeks of effective TB
- •- Obtained written informed consent
排除标准
- •- Patients that are pregnant, or breast feeding - History of adverse events on
- •previous or current INH use - FEV1 < 30% predicted - Concurrent use of
- •corticosteroids in varying dose (a stable dose one week before participating
- •and during the study is allowed). - Concurrent use of aluminum containing
- •medicines (i.e. antacids) - Concurrent use of carbamazepine, phenytoin or
- •theophylline Additionally, a potential subject with DS-TB (eliciting switch to
- •levofloxacin) who meets any of the following criteria will be excluded from
- •participation in this study: • History of epilepsy • History of adverse events
- •on previous levofloxacin or other fluorquinolone use • Risk of QTc prolongation
- •(prolonged QTc-interval (>450 msec), long-QT syndrome (LQTS) or concurrent use
- •of high risk QTc prolongating drugs (amiodarone, erythromycin (daily dose >
- •1000 mg) or sotalol)
研究者
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