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

NCT07324291 | Not Yet Recruiting

• 1 other identifier: QTJC2024065
• Study Type: observational
• Target: 1,000
• Locations: 0 countries
• Sites: N/A

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. 1.What is the incidence of perianal MBL-CRE colonization following allogeneic HSCT?
2. 2.Among colonized patients, what proportion subsequently develop MBL-CRE infections?
3. 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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Incidence of MBL-CRE Infection Among Colonized Patients.

  From the time of colonization to 6 months after HSCT.

• Infection-Related Mortality.

  28 days after documented onset of MBL-CRE infection.

• All-Cause Mortality.

  28 days after documented onset of MBL-CRE infection.

• Clinical Cure Rate

  28 days (range: 25-31 days) after initiation of antimicrobial therapy

• Microbiological Eradication Rate.

  14 days (range: 11-17 days) and 28 days (range: 25-31 days) after initiation of antimicrobial therapy.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• Engraftment failure.

Sponsors & Collaborators

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

Biospecimen

Retention: SAMPLES WITH DNA

Biospecimens (perianal swab isolates of CRE) will be retained. DNA will be extracted from MBL-CRE isolates for whole-genome sequencing.

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 23, 2025
• First Posted: January 7, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: January 7, 2026

Record last verified: 2025-11