Specific post-marketing surveillance of Geninax(R) Tablets 200 mg Efficacy and safety against atypical pneumonia - Specific post-marketing surveillance of Geninax(R) Tablets 200 mg Efficacy and safety against atypical pneumonia
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 100
研究概览
简要总结
The safety in 105 patients and the efficacy in 71 patients were examined. 1. The efficacy rates among patients suspected of having atypical pneumonia and those with a confirmed diagnosis of atypical pneumonia were 94.8% (55/58 patients). The efficacy rate was 4/4 for patients in whom Chlamydophila pneumoniae was detected (including 1 patient with a polymicrobial infection with another bacterial strain) and 90% (9/10 patients) for patients in whom Mycoplasma pneumoniae was detected (garenoxacin was ineffective in 1 of 2 patients with a polymicrobial infection with another bacterial strain). 2. The incidence of adverse drug reactions (including abnormal laboratory tests) was 4.8% (5/105 patients). Among the adverse drug reactions, gastrointestinal disorders, infection and infestation, nervous system disorder, and skin and subcutaneous tissue disorder were observed in 2.9% of patients (3/105), 1.0% (1/105), 1.0% (1/105), and 1.0% (1/105), respectively.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 15years-old 至 ot applicable（—）
- 性别
- All
入选标准
- 未提供
排除标准
- •Patients who had a history of hypersensitivity to Geninax(R) Tablets or other quinolones Patients who were pregnant or possibly pregnant or were lactating Patients who were previously enrolled in the study Patients in whom drug efficacy of Geninax(R) Tablets was difficult to assess Other patients whom the primary physician deemed to be ineligible as a target