EUCTR2017-004531-36-DE进行中（未招募）1 期
Escherichia coli strain Nissle 1917 - Suspension for treatment of patients with Clostridium difficile associated diarrhoea - NIDIFF-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
- 108
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
- •oSigned informed consent form by the patient
- •oC. difficile associated diarrhoea (illnesses of mild to moderate severity)
- •oAge = 18 years with life expectancy of 3 months or more
- •oPositive detection of C. difficile protein GDH and toxin A and / or B and diarrhoea (definition: = 3 liquid or watery stools per day or = 8 in 48 h)
- •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 18
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 90
排除标准
- •oNon-fulfilment of at least one inclusion criterion
- •oParticipation in an interventional clinical trial according to the German medicines act (AMG) within the last 30 days or simultaneously
- •oExpectable lack of cooperation/compliance
- •oWomen of childbearing potential without conceptual protection
- •oPregnancy and breast feeding period
- •oAbuse of alcohol (daily intake of 20 g of pure alcohol in women and 30 g of pure alcohol in men), medications or drugs
- •oLimited legal capacity
- •oHousing in an institution as a result of official or court orders
- •oDependency of a person on sponsor, trial site or investigator
- •oIncompatibility with study medication
- •oNecessity of intake of other antidiarrhoeals, especially antimotility agents
- •oOther reasons that, in the opinion of the examiner, speak against inclusion of the patient to the trial
- •oThe presence of more than 2 of the following predictors of increased risk of a severe CDAD progression:
- •? Fever > 38.5 °C
- •? Leucocytosis > 15 × 10^9/L
- •? Left shift > 20% rod meaty granulocytes
- •? Hypoalbuminemia < 30 g/L
- •? Creatinine increase > 50% of initial value
- •? Lactate boost = 5mmol/l
- •? Age > 75 years
- •? Significant morbidity (e.g. renal failure, immune suppression, etc.)
- •oSevere form of the CDAD/ C. difficile infection (CDI):
- •Severe CDAD/CDI is defined as an episode of CDAD/CDI with (one or more specific signs and symptoms of) severe colitis or a complicated course of disease, with significant systemic toxin effects and shock, resulting in need for intensive care unit (ICU) admission, colectomy or death
- •oEnterocolitis that is not associated with C. difficile infection, such as active Crohn's disease*, active ulcerative colitis*, colitis caused by radiation or other pathogen-induced colitis
- •oPositive TPER-Test (test will only be performed on patients with community acquired CDAD)
- •oOther serious comorbidities, which, in the opinion of the investigator, call into question the protocol-compliant implementation of the study. This applies in particular to comorbidities, which could worsen if there is an aggravation of the CDAD.
- •oNon-deductibility of a current antibiotic treatment of a disease other than the CDAD.
- •oIntake of more than three 400 mg-doses of metronidazole (daily dose) or longer than 24 hours of metronidazole therapy to treat the acute CDAD episode before enrolment into the study.
- •oIntake of more than four 125 mg-doses of vancomycin (daily dose) or longer than 24 hours of vancomycin therapy to treat the acute CDAD episode before enrolment into the study.
- •oTaking more than three doses or longer than 24 hours of a probiotic drug to treat the acute CDAD episode before enrolment into the study.
- •* Patients in remission are not excluded from the study!
研究者
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