EUCTR2005-004851-37-DE进行中（未招募）不适用
Doppelblinde, randomisierte, prospektive multizentrische klinische Studie zur Definition der optimalen antibiotischen Therapiedauer bei Patienten mit unkomplizierter akuter Cholangitis: Moxifloxacin oral vs. Placebo oral nach Entfieberung zur Fortführung der initial intravenösen Therapie mit Moxifloxacin.Duration of Moxifloxacin therapy for acute cholangitis –a randomized, placebo-controlled, multicenter study.The MONA LISA study. - The Mona Lisa Study
Freistaat Bayern, vertreten durch die Universität Regensburg, Klinikum0 个研究点目标入组 264 人开始时间: 2007年12月10日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 264
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
- •- adult age (= 18 years)
- •- acute uncomplicated cholangitis, defined as follows (all 3 criteria must be met):
- •1. aute febrile disease:
- •(temperatur = 38.0°C at least once in the 24 Stunden prior or after the time point of hospital admission, duration of febrile disease not longer than 7days)
- •2. Cholestasis documented by at least one imaging technique (sonographie / CT / ERCP / MRCP; maximal diameter of the common bile duct>7 mm, >10 mm for patients with prior cholecystectomy)
- •3. Obstruction of the common bile duct provenly or probably caused by biliary concrement(s) in the middle or distal third of the common bile duct.
- •- Written informed consent.
- •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
- •- Cholangitis, not caused by biliary concrements
- •- Manifested Pankreatitis (not assymptomatic elevation of serum lipase)
- •- Severe sepsis (defined as sepsis with greater or equal of one organfailure or necessary intensive care greater than 24 hours)
- •- Intervention ot the biliary tract (ERCP / PTCD / Operation) in the 14 days prior to hospital admission
- •- Oral antibiotic treatment longer than 48 hours prior to hospital admission
- •- Antibiotic therapy with any other antibiotic than moxifloxacin for longer than 24 hours after hospital admission
- •- Pregnancy, breast-feeding mothers, or women for whom a pregnancy can´t be rouled out
- •- Known intolerance, allergy or contraindication(s) for moxifloxacin or other fluoroquinolones
- •- Advanced liver cirrhosis (Child-Pugh stage C)
- •- Chronic liver diseases with elevation of transaminases above 5-time the upper limit of normal
- •- Terminal renal failure neccessitating dialysis
- •- Life exspectancy below 3 month
- •- Severe immunosuppression (= 20mg prednisolon per day, or any other medical immunosuppression, patients with known HIV–infection, patients with prior transplantations (BMT or solid organ)
- •- Chemotherapy for a malignant disease in the 14 day prior or during the study period
- •- Known epilepsy
- •- Clinical relevant bradykardia (HR continiously < 40/min)
- •- Symptomatic arrhythmias in the medical history (not atrial fibrilation)
- •- Clinical relevant heart insufficiency (leftventricular EF<30%)
- •- Known concgenital or sporadic QTc-Prolongation or concommittant use of medication that prolongs the QTc-interval (e.g. cisapride, antiarrhythmic drugs of the class IA and III like amiodarone, sotalol, disopyramid, chinidine and procainamide)
- •- Disturbancies of serum electrolytes, especially untreated hypokalemia
- •- Tendon-related problems that occured during prior treatment with a fluoroquinolone
- •- Known or suspected additional bacterial infection neccessitating additional systemic antibiotic therapy
- •- Prior participation in this study or participation in any therapeutic study in the 30 days prior to the hospital admission or during the study period
研究者
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