EUCTR2014-003727-22-NL进行中（未招募）不适用
A randomized controlled multicenter trial of a five day course of oral colistin and neomycin followed by restoration of the gut microbiota using fecal transplantation to eradicate intestinal carriage of extended spectrum beta-lactamase or carbapenemase-producing Enterobacteriaceae in high-risk patients - R-GNOSIS WP3
Geneva University Hospitals0 个研究点目标入组 104 人开始时间: 2014年11月27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
- 104
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 patients (>= 18 years at date of inclusion)
- •- Documented intestinal carriage of ESBL-E and / or CRE by stool culture at baseline (visit 0)
- •- IF COLONIZED WITH ESBL-E ONLY (WITHOUT CRE): At least one episode of symptomatic infection
- •with ESBL-E requiring systemic antibiotic therapy within the last 180 days before date of inclusion
- •(based on the last day of antibiotic therapy for that infection)
- •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 52
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 52
排除标准
- •- Pregnancy or planned pregnancy
- •- Breastfeeding
- •- Difficult / impossible follow-up
- •- Allergy or other contraindication to one of the study drugs
- •- Anatomic contraindication to the placement of a nasogastric tube
- •- Recurrent aspirations
- •- Resistance to colistin (defined as MIC> 2 mg/l) of any of the ESBL-E or CRE strains isolated at baseline
- •- Estimated life expectancy < 6 months
- •- Treatment with any systemic antibiotic on the day of inclusion
- •- Severe immunodeficieny
- •? Systemic chemotherapy =30 days from baseline or planned chemotherapy within the next 6 months
- •? Human Immunodeficiency Virus (HIV) with CD4 count < 250/mcl
- •? Prolonged use of steroids (prednisone equivalent = 60 mg per day for >= 30 days) or other immunosuppressive medications
- •? neutropenia with absolute neutrophil count <1000/µL,
- •? Solid organ transplant recipient
- •? Hematopoeitic stem cell transplant recepients
- •? Other causes of severe immunodeficiency
- •- Hospitalization in an Intensive Care Unit
- •- Estimated glomerular filtration rate (CKD-EPI) < 15 ml/min/1.73m2
- •- Severe food allergy (anaphylaxis, urticaria)
研究者
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