EUCTR2005-000771-18-DE进行中（未招募）不适用
Prospective, doubleblind, randomized multicenter study to proof the clinical and bacteriological non-inferiority of amoxicillin versus moxifloxacin in hospitalized patients with non-severe community-acquired pneumonia - PENCAP
niversitätsklinikum Ulm0 个研究点目标入组 290 人开始时间: 2006年5月17日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 290
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
- •men or women older than 18 years with signed informed consent • women in a childbearing age with sufficient conception protection or if necessary negative pregnancy test • infiltrates appeared newly in the x-ray thorax • breath-conditioned chest pain • at least two of the following clinical symptoms of a pneumonia o cough which is newly appeared or increasing o dyspnea o mucopurulent or purulent sputum o fever (body temperature >=37.8 degrees Celsius auricalary and/or >= 38,3°C rectal) o o positive auscultation•negative legionella antigen test in the urine •CRB-65-Index<3
- •Are the trial subjects under 18? no
- •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
- •Hospitalization within the last 28 days (except for the last 72 h) • Participation in another therapy study within the last 4 weeks with studies admission • intake of an antibiotic longer than 24 hrs within the last 72 hours before studies admission • Patients in the pregnancy and nursing phase • Existence of contraindications opposite the examining preparations or other B-Lactam antibiotics or fluorochinolons • Patients with a CURB-Index >=3 • Patients with suspicion of pneumonia • Patients with suspicion of retrostenotic Pneumonia because of bronchial obstruction • Patients with suspicion of nosocomial Pneumonia • Patients with an infection by a known or suspected resistant pathogene
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