Perianal MBL-CRE Colonization and Infection in Allogeneic Hematopoietic Stem Cell Transplant Patients

NCT ID: NCT07324291

Last Updated: 2026-01-07

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 1000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2026-01-31
• Study Completion Date: 2027-06-30

Brief Summary

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.

Conditions

ALLOGENEIC HEMATOPOIETIC STEM CELL TRANSPLANTATION; Carbapenem-resistant Enterobacterales

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• Adult patients (≥18 years) who received allogeneic hematopoietic stem cell transplantation;

Exclusion Criteria

• Engraftment failure.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institute of Hematology & Blood Diseases Hospital, China

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

QTJC2024065

Identifier Type: -

Identifier Source: org_study_id