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

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07324291

Enrollment

1000

Registered

2026-01-07

Start date

2026-01-31

Completion date

2027-06-30

Last updated

2026-01-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ALLOGENEIC HEMATOPOIETIC STEM CELL TRANSPLANTATION, Carbapenem-resistant Enterobacterales

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

* Engraftment failure.

Design outcomes

Primary

Measure	Time frame	Description
Incidence of perianal MBL-CRE colonization.	Within 100 days after allogeneic HSCT.	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

Measure	Time frame	Description
Infection-Related Mortality.	28 days after documented onset of MBL-CRE infection.	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.	28 days after documented onset of MBL-CRE infection.	The proportion of patients with MBL-CRE infection who die from any cause within 28 days after infection onset.
Incidence of MBL-CRE Infection Among Colonized Patients.	From the time of colonization to 6 months after HSCT.	The proportion of patients with documented perianal MBL-CRE colonization who subsequently develop MBL-CRE clinical infection.
Microbiological Eradication Rate.	14 days (range: 11-17 days) and 28 days (range: 25-31 days) after initiation of antimicrobial therapy.	The proportion of infected patients with documented clearance of MBL-CRE from repeat culture specimens after treatment.
Risk Factors for MBL-CRE Colonization and Infection	From transplantation to 6 months post-transplant.	Identification of clinical, demographic, and treatment-related variables associated with perianal MBL-CRE colonization and subsequent infection.
Clinical Cure Rate	28 days (range: 25-31 days) after initiation of antimicrobial therapy	The proportion of MBL-CRE-infected patients who achieve complete clinical resolution of infection-related signs and symptoms after treatment.

Outcome results