About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adult patients (≥18 years) who received allogeneic hematopoietic stem cell transplantation;
Disqualifiers
Engraftment failure.
Trial population
Adult patients (≥18 years) who received allogeneic hematopoietic stem cell transplantation.
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
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).
Secondary outcomes
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.
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.
All-Cause Mortality.
The proportion of patients with MBL-CRE infection who die from any cause within 28 days after infection onset.
Clinical Cure Rate
The proportion of MBL-CRE-infected patients who achieve complete clinical resolution of infection-related signs and symptoms after treatment.
Locations
Sponsors and contacts
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