EUCTR2006-006984-21-DE进行中（未招募）不适用
prospective, randomized, open, multicentre trial to assess the influence of empiric antibiotic monotherapy with meropenem (Meronem) versus combination with moxifloxacin (Avalox) on the organ function of patients with severe sepsis and septic shock
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
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
- •- Presence of severe sepsis or septic shock according to the definitions of the SepNet
- •- Beginning of severe sepsis or of septic shock within the last 24 hours
- •- written informed consent of the patient or his court-appointed guardian
- •- women of child bearing potential using contraception with a failure rate of less than 1% per year
- •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
- •- Age < 18 years
- •- pregnancy (women of child bearing potential with positive pregnancy test)
- •- nursing women
- •- prior treatment with meropenem, imipenem or ertapenem within the last four weeks (> one daily dose)
- •- prior treatment with moxifloxacin, ciprofloxacin or levofloxacin within the last four weeks (> one daily dose)
- •- prior treatment with pseudomonas-specific cephalosporins (f.e. cefepime, ceftazidim, cefpirom) or piperacillin within the last 48 hours (> one daily dose)
- •- presence of infection where guidelines recommend an antimicrobiological therapy other than the study drug (f.e. active endocarditis)
- •- proven or urgent clinical suspicion of a pathogen where study drug is not effective (f.e. active tuberculosis, infection with MRSA or VRE)
- •- known allergy to the trial medication
- •- diseases or impairments affecting the tendons after a previous therapy with chinolon-derivatives
- •- documented congenital or acquired elongation of the QT-interval
- •- simultaneous application of other medications resulting in elongated QT-intervals should be avoided
- •- electrolyte imbalance, particularly patients with uncorrected hypokalemia
- •- clinically significant bradycardia
- •- clinically significant heart insufficiency with reduced left-ventricular ejection fraction
- •- symptomatic arrhythmia in anamnesis
- •- decreased liver function (Child Pugh C) and / or transaminase level more than fivefold the normal value
- •- therapy restriction (e. g. DNR-order)
- •- bad prognosis due to accompanying disease(s)
- •- concurrent or previous (within the last 30 days) participation in other clinical trials
- •- close relationship to the trial physician (co-workers, relatives, colleagues)
研究者
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