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: 1. What is the incidence of perianal MBL-CRE colonization following allogeneic HSCT? 2. Among colonized patients, what proportion subsequently develop MBL-CRE infections? 3. 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.
Study Type
OBSERVATIONAL
Enrollment
1,000
Incidence of perianal MBL-CRE colonization.
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).
Time frame: Within 100 days after allogeneic HSCT.
Incidence of MBL-CRE Infection Among Colonized Patients.
The proportion of patients with documented perianal MBL-CRE colonization who subsequently develop MBL-CRE clinical infection.
Time frame: From the time of colonization to 6 months after HSCT.
Infection-Related Mortality.
The proportion of patients with MBL-CRE infection who die due to infection-related causes within 28 days after onset of infection.
Time frame: 28 days after documented onset of MBL-CRE infection.
All-Cause Mortality.
The proportion of patients with MBL-CRE infection who die from any cause within 28 days after infection onset.
Time frame: 28 days after documented onset of MBL-CRE infection.
Clinical Cure Rate
The proportion of MBL-CRE-infected patients who achieve complete clinical resolution of infection-related signs and symptoms after treatment.
Time frame: 28 days (range: 25-31 days) after initiation of antimicrobial therapy
Microbiological Eradication Rate.
The proportion of infected patients with documented clearance of MBL-CRE from repeat culture specimens after treatment.
Time frame: 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
Identification of clinical, demographic, and treatment-related variables associated with perianal MBL-CRE colonization and subsequent infection.
Time frame: From transplantation to 6 months post-transplant.
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