Perianal MBL-CRE Colonization and Infection in Allogeneic Hematopoietic Stem Cell Transplant Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: ALLOGENEIC HEMATOPOIETIC STEM CELL TRANSPLANTATION, Carbapenem-resistant Enterobacterales. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Prospective Cohort Study of Perianal MBL-CRE Colonization and Infection in Allogeneic Hematopoietic Stem Cell Transplant Recipients
Overview
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.
Primary outcome measures
- Incidence of perianal MBL-CRE colonization. [Time frame: Within 100 days after allogeneic HSCT.]
Secondary outcome measures (6)
- Incidence of MBL-CRE Infection Among Colonized Patients. [Time frame: From the time of colonization to 6 months after HSCT.]
- Infection-Related Mortality. [Time frame: 28 days after documented onset of MBL-CRE infection.]
- All-Cause Mortality. [Time frame: 28 days after documented onset of MBL-CRE infection.]
- Clinical Cure Rate [Time frame: 28 days (range: 25-31 days) after initiation of antimicrobial therapy]
- Microbiological Eradication Rate. [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 [Time frame: From transplantation to 6 months post-transplant.]
Eligibility criteria
Inclusion criteria
- Adult patients (≥18 years) who received allogeneic hematopoietic stem cell transplantation;
Exclusion criteria
- Engraftment failure.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07324291 · QTJC2024065