Prospective Cohort Study of Perianal MBL-CRE Colonization and Infection in Allogeneic Hematopoietic Stem Cell Transplant Recipients
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 1,000
- 主要终点
- Incidence of perianal MBL-CRE colonization.
研究概览
简要总结
The goal of this observational study is to characterize the clinical features of metallo-β-lactamase-producing carbapenem-resistant Enterobacterales (MBL-CRE) colonization and subsequent infection in patients after allogeneic hematopoietic stem cell transplantation (HSCT). The study aims to estimate the incidence of perianal MBL-CRE colonization, the proportion of subsequent infections, the associated risk factors, mortality, and the underlying antibiotic resistance mechanisms.
The main questions this study seeks to answer are:
- What is the incidence of perianal MBL-CRE colonization following allogeneic HSCT?
- Among colonized patients, what proportion subsequently develop MBL-CRE infections?
- What are the risk factors for colonization and infection, the patterns of antimicrobial resistance, and the mortality among infected patients? Participants will undergo perianal swab screening for CRE as part of their routine post-transplant care. MBL-CRE isolates identified from perianal swabs will undergo antimicrobial resistance genomic analysis to investigate bacterial transmission dynamics and resistance mechanisms.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients (≥18 years) who received allogeneic hematopoietic stem cell transplantation;
排除标准
- •Engraftment failure.
结局指标
主要结局
Incidence of perianal MBL-CRE colonization.
时间窗: Within 100 days after allogeneic HSCT.
The proportion of patients who develop perianal colonization with metallo-β-lactamase-producing carbapenem-resistant Enterobacterales (MBL-CRE) following allogeneic hematopoietic stem cell transplantation (HSCT).
次要结局
- Clinical Cure Rate(28 days (range: 25-31 days) after initiation of antimicrobial therapy)
- All-Cause Mortality.(28 days after documented onset of MBL-CRE infection.)
- Incidence of MBL-CRE Infection Among Colonized Patients.(From the time of colonization to 6 months after HSCT.)
- Infection-Related Mortality.(28 days after documented onset of MBL-CRE infection.)
- Microbiological Eradication Rate.(14 days (range: 11-17 days) and 28 days (range: 25-31 days) after initiation of antimicrobial therapy.)
- Risk Factors for MBL-CRE Colonization and Infection(From transplantation to 6 months post-transplant.)