ascufloxacin penetration into otorhinolaryngological tissues study - LSPOT Study

Suzuki Kenji0 个研究点目标入组 14 人开始时间: 2020年11月26日最近更新: 2023年10月17日

试验速览

阶段: 未知
状态: 已完成
发起方: Suzuki Kenji
入组人数: 14

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

Compared to other tissues, concentration of lascufloxacin tended to be lower in the middle ear mucosa. Nevertheless, high tissue migration rate was observed in all tissues. No death, serious adverse event, and side effect was reported.

研究设计

研究类型: Interventional

入排标准

年龄范围: >= 20age old 至 ot applicable（—）
性别: All

入选标准

•Patients who meet all of the following criteria are included in this study;
•1. Male and female aged 20 years or older at giving their consent
•2. Patients who require tissue resection surgery in the following tissues with hospitalization (paranasal sinus mucosa (maxillary sinus mucosa, ethmoid sinus mucosa), middle ear mucosa, or palatine tonsil tissue)
•3. Patients with indication of lascufloxacin
•4. Patients who provide their consent in a written form by themselves from their free will after full explanation of the study from the responsible investigator and the understanding of the study

排除标准

•Patients who fall into any of the following criteria are excluded from participating in this study;
•1. Patients with hypersensitivity or with history of severe side effects of quinolone antibacterial agents
•2. Patients who are pregnant or possibly pregnant
•3. Patients with severe hepatic or renal dysfunction
•4. Patients with history of malignant tumor in the tissue which is planned to be resected, or patients with history of surgery in the tissue which is planned to be resected
•5. Patients who were treated with quinolone antibacterial agents within 5 days before the administration of the study agent
•6. Patients who are planned to be treated with the prohibited agents during the study period
•7. Patients with habit of excess drinking or smoking
•8. Patients with other conditions that the responsible investigator think inappropriate to participate in the study

研究者

发起方

Suzuki Kenji

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