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NCT Number: NCT07324291

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

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.

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Key information

Conditions

Allogeneic Hematopoietic Stem Cell Transplantation Carbapenem-resistant Enterobacterales

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Engraftment failure.

Treatment and study plan

Primary outcomes

  1. Incidence of perianal MBL-CRE colonization.

    Time frame: 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 outcomes

  1. Incidence of MBL-CRE Infection Among Colonized Patients.

    Time frame: 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.

  2. Infection-Related Mortality.

    Time frame: 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.

  3. All-Cause Mortality.

    Time frame: 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.

  4. Clinical Cure Rate

    Time frame: 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.

  5. Microbiological Eradication Rate.

    Time frame: 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.

  6. Risk Factors for MBL-CRE Colonization and Infection

    Time frame: From transplantation to 6 months post-transplant.

    Identification of clinical, demographic, and treatment-related variables associated with perianal MBL-CRE colonization and subsequent infection.

Sponsors and collaborators

Lead sponsor

Institute of Hematology & Blood Diseases Hospital, China

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jan 7, 2026
Registry last updated
Jan 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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