Decolonization of Carbapenem-resistant Enterobacterales (CRE) in Patients With Faecal Carriage of CRE With Neomycin
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Number of patients with microbiological eradication at 2 weeks after neomycin administration
研究概览
简要总结
Rates of antimicrobial resistance are increasing worldwide. There is increasing evidence that physiological gut microbiota is a large reservoir of antibiotic-resistance genes. Healthy gut microbiota is known to prevent the colonization of the gastrointestinal tract by pathogens, the so-called mechanism of colonization resistance, but this protective mechanism can be altered by therapies that impair gut microbiota, including antibiotics with consequent colonization of gut pathogens, including carbapenem-resistant Enterobacterales (CRE). CRE carriers represent an epidemiological threat to other hospitalized patients and to the whole community, but are also at risk of developing clinical consequences of this colonization, including bloodstream infections from these pathogens. Neomycin has shown high efficacy in the eradication of CRE invitro. Neomycin has also been approved to treat hepatic coma by eradicating bacterial in gastrointestinal tract. Therefore, this evidence suggests that this procedure could be useful in eradicating CRE.
However, current evidence is mostly limited.
The aim of this study is to investigate the efficacy of Neomycin, compared with no intervention in eradicating gut colonization from CRE.
详细描述
The investigators will randomize patients colonized by CRE (diagnosed by rectal swab) to Neomycin by stratified randomization according to type of CRE species (E.coli or non-E.coli). Then, patients will be followed up, rectal swabs will be repeated, and stool samples for culture and will be collected, up to 14 days after Neomycin.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 95 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient aged >18 years
- •Hospitalized in medical wards
- •Presence of CRE in stool/rectal swab without symptom from active surveillance of CRE
- •Sign informed consent to participate the study
排除标准
- •CRE infected patients
- •Receiving anti-CRE antibiotics
- •Known allergy to neomycin or other aminoglycosides
- •Receiving Cidofovir, Colistin methate sodium, foscarnet , furosemide, digoxin
- •eGFR (estimated Glomerular Filtration Rate) < 30 ml/min/1.73 m2
- •Had gastro-intestinal tract diseases
- •Pregnancy or breast-feeding
研究组 & 干预措施
Neomycin
Patients enrolled in this arm will receive Neomycin.
干预措施: Neomycin (Drug)
结局指标
主要结局
Number of patients with microbiological eradication at 2 weeks after neomycin administration
时间窗: 2 weeks
Microbiological eradication is defined as the disappearance of CRE in hospitalized patients' faces at 2 weeks after neomycin administration
次要结局
- Incidence of ์Neomycin toxicity (safety)(2 weeks)
- Number of CRE isolates susceptible to amikacin at 2 weeks after neomycin administration(2 weeks)
- Incidence of ์carbapenemases in isolated CRE(2 weeks)
- Number of CRE isolates susceptible to neomycin at 2 weeks after neomycin administration(2 weeks)
- Number of CRE isolates susceptible to gentamicin at 2 weeks after neomycin administration(2 weeks)