NL-OMON43965已完成2 期
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 - RGNOSIS WP3
Prof. Stephan Harbarth; Hôpitaux Universitaires de Genève (HUG)0 个研究点目标入组 26 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 26
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •For patients:
- •- 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).;For donors:
- •- Be aged between 18 and 60 years.
- •- Be in good health without comorbidities or significant past medical history.
- •- Have a normal body weight (body mass index between 20 and 25 kg/m2).
- •- Have a normal macroscopic appearance of stool.
- •- Have a normal stool frequency (1-3x/day).
排除标准
- •For patients:
- •- 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/*L.
- •* 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).;For donors:
- •- Not have an acute or chronic digestive disorder.
- •- Not have a risk behavior for infectious diseases (eg recent change of sexual partner, homosexual intercourse, drug use etc.).
- •- Not be affected by a chronic disease.
- •- Not be under long-term treatment.
- •- Not have had an acute illness or fever in the last 4 weeks.
- •- Not have stayed in a tropical zone in the last three months or have lived in tropics for many years.
- •- Not have taken antibiotics in the last 6 months.
- •- Not have received a tattoo, piercing etc. in the last 6 months.
- •- Not have undergone a gastroscopy or colonoscopy within the last 6 months.
- •- Not have received blood products in the past 12 months.
- •- Not have a history of typhoid fever.
- •- Not have been hospitalized aborad in the last 12 months.
- •- Not have stayed in the UK for more than six months between 1980 and 1996.
研究者
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