NL-OMON54672招募中不适用
Faecal microbiota transfusion for decolonization of multidrug resistant Enterobacteriaceae in renal transplant recipients (RESET): a pilot study. - RESET
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 12
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 64（—）
入选标准
- •In order to be eligible to participate in this study, a subject must meet all
- •of the following criteria: 1. Competent renal transplant recipient aged 18 or
- •above. 2. Intestinal carriage of extended-spectrum β-lactamase
- •Enterobacteriaceae (ESBL-E) and/or carbapenemase producing Enterobacteriaceae
- •(CPE) by rectal swab or stool culture tests (>=2x). 3. A history of >= 1
- •documented infection by these bacteria <6 months before enrolment. 4.
- •Adequate understanding of the procedures of the study and agrees to abide
- •strictly thereby. 5. Ability to communicate well with the investigators and
- •availability attend all study visits. 6. Signed informed consent.
排除标准
- •1. Need for systemic antibiotics. 2. ICU admission at enrolment. 3. Creatinine
- •clearance <30 ml/min. 4. (Planned) pregnancy during study. 5. Allergy /
- •contraindication study drugs. 6. Recurrent aspirations / chronic dysphagia. 7.
- •Recent intra-abdominal surgery. 8. A history of acute rejection within 6 months
- •before enrolment. 9. Treatment with alemtuzumab within 6 months before
- •enrolment. 10. Treatment with of eculizumab within 3 months before enrolment.
- •11. Clinical signs of active colitis / gastro-enteritis, including active
- •infections (EBV /CMV / adenovirus / Clostridium difficile / chronic parasitic
- •infection) or active inflammatory bowel disease. 12. Severe food allergy.
研究者
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¡®Faecal microbiota transfusion for decolonization ofmultidrug resistant Enterobacteriaceae in renaltransplant recipients (RESET): a pilot study.¡¯multi drug resistance colonizationrenal transplant recipientsMDR infectionsfaecal microbiota transfusionNL-OMON22882Department of Infectious Diseases and Medical Microbiology, Leiden University Medical Center12
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