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

Prospective Cohort Study of Perianal MBL-CRE Colonization and Infection in Allogeneic Hematopoietic Stem Cell Transplant Recipients

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 Overview

• Status: Not yet recruiting
• Conditions: ALLOGENEIC HEMATOPOIETIC STEM CELL TRANSPLANTATION; Carbapenem-resistant Enterobacterales

• Study Type: Observational
• Enrollment (Estimated): 1000

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Engraftment failure.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	Within 100 days after allogeneic HSCT.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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.	From transplantation to 6 months post-transplant.

Collaborators and Investigators

• Sponsor: Institute of Hematology & Blood Diseases Hospital, China

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027

Study Registration Dates

• First Submitted: December 23, 2025
• First Submitted That Met QC Criteria: December 23, 2025
• First Posted (Actual): January 7, 2026

Study Record Updates

• Last Update Posted (Actual): January 7, 2026
• Last Update Submitted That Met QC Criteria: December 23, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: QTJC2024065

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No