EUCTR2006-006220-19-CZ进行中（未招募）1 期
Safety and Efficacy of Sumamed® Therapy in the Treatment of Respiratory Tract Infections in Adults and Children: International, Multicenter, Non-Comparative Study - SuPoRTI Study
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 2,000
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Male or female out-patients
- •Acute onset of disease indicated by presence of body temperature ( >37oC)
- •Presence of at least 2 specific clinical signs and symptoms (depending on the diagnosis)
- •X-ray confirmation of CAP
- •Signed informed consent (for minors, parent or legal guardian written consent needs to be obtained)
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Hypersensitivity to macrolides
- •Treatment with any antibiotic within 14 days prior to enrollment
- •Participation in any clinical study within 4 weeks prior to enrollment
- •Prior enrollment in this study
- •Tachypnea (> 20 breaths/min for adults, or more than two standard deviations appropriate for the age of the child)
研究者
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