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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorInstitute of Hematology & Blood Diseases Hospital, China

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Engraftment failure.

Trial population

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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

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).

Time frame
Within 100 days after allogeneic HSCT.

Secondary outcomes

1

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.

Time frame
From the time of colonization to 6 months after HSCT.
2

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.

Time frame
28 days after documented onset of MBL-CRE infection.
3

All-Cause Mortality.

The proportion of patients with MBL-CRE infection who die from any cause within 28 days after infection onset.

Time frame
28 days after documented onset of MBL-CRE infection.
4

Clinical Cure Rate

The proportion of MBL-CRE-infected patients who achieve complete clinical resolution of infection-related signs and symptoms after treatment.

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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