2024-516393-29-00招募中3 期
FECES - Fecal transplantation to Eradicate Colonizing Emergent Superbugs
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 299
- 试验地点
- 1
- 主要终点
- Proportion of subjects not carrying MDR-GNB (neither carbapenem-resistant Enterobacteriaceae [CRE] nor extended spectrum β-lactamase producing Enterobacteriaceae [ESBL-E]) at 30 ± 10 days after randomization, as determined by culture methods
研究概览
简要总结
Determine whether FMT with frozen capsules is effective for decolonization of MDR-GNB at 30±10 days post-randomization
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •Patient: ≥ 18 years and < 105 years
- •Patient: Patient with at least one positive rectal swab for enterobacteria: extended-spectrum β-lactamase-producing Enterobacteriaceae (ESBL-E) or carbapenem-resistant Enterobacteriaceae (CRE), or who have had an ESBL-E or CRE infection within the year For ESBL-E carriers: an ESBL-E infection within the year is mandatory
- •Patient: Patient able to take 50 capsules orally in a day and without swallowing disorders
- •Donor: Healthy subjects ≥ 18 years and < 50 years
- •Donor: Body mass index <30 kg/m2
- •Donor: Regular bowel movement defined as at least 1 stool every 2 days and maximum than 3 stools per day
- •Donor: See protocol for details of clinical and biological criteria
排除标准
- •Patient: Current antibiotic treatment with the exception of long term antibiotic prophylaxis (duration of at least 3 months/year)
- •Patient: Patient under legal protection
- •Patient: Participation in another interventional study
- •Patient: No-affiliation to a social security scheme
- •Patient: Refusal to participate to the study
- •Donor: Any history of or current proctologic disease or any acute condition, which in the investigator’s judgment could harm the volunteer and / or compromise or limit the evaluation of the protocol or data analysis
- •Donor : Subject under AME
- •Patient : Patient under AME
- •Donor: Subject under legal protection
- •Donor: Participation in any other interventional study
- •Donor: No-affiliation to a social security scheme
- •Donor: Refusal to participate to the study
- •Donor: See protocol for details of clinical and biological criteria
- •Patients: Patients hospitalized in the intensive care unit
- •Patient: Pregnancy or breastfeeding during the study
- •Patient: Women of childbearing potential who are unwilling or unable to use an acceptable method of birth control [such as oral contraceptives, other hormonal contraceptives (vaginal products, skin patches, or implanted or injectable products), or mechanical products such as an intrauterine device or barrier methods (condoms)] to avoid pregnancy for the entire study
结局指标
主要结局
Proportion of subjects not carrying MDR-GNB (neither carbapenem-resistant Enterobacteriaceae [CRE] nor extended spectrum β-lactamase producing Enterobacteriaceae [ESBL-E]) at 30 ± 10 days after randomization, as determined by culture methods
Proportion of subjects not carrying MDR-GNB (neither carbapenem-resistant Enterobacteriaceae [CRE] nor extended spectrum β-lactamase producing Enterobacteriaceae [ESBL-E]) at 30 ± 10 days after randomization, as determined by culture methods
次要结局
未报告次要终点
研究者
Coordinating Investigator
Scientific
Assistance Publique Hopitaux De Paris
研究点 (1)
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