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Dynamics of Colonization and Infection by Multidrug-Resistant Pathogens in Immunocompromised and Critically Ill Patients

Dynamics of Colonization and Infection by Multidrug-Resistant Pathogens in Immunocompromised and Critically Ill Patients

Recruiting
18 years and older
All
Phase N/A

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Overview

The goal of this observational study is to investigate how bacterial populations from the intestine and mouth of patients change during the hospitalization period and evaluate if some populations of specific bacteria increase or decrease the risk of acquiring an infection or becoming colonized by pathogenic bacteria. Participants will have the following samples collected during enrollment: stool samples (maximum 2x/week), blood draws (1x/week), oral swab (1x/week).

Description

The objectives of this study are to dissect the main microbial, clinical, and antimicrobial resistance determinants that impact colonization and infection by vancomycin-resistant enterococci (VRE), extended-spectrum beta-lactamase producing Enterobacterales (ESBL-E), carbapenem-resistant Enterobacterales (CRE), and Clostridium difficile; to evaluate the role of commensal microbiota in VRE, ESBL-E/CRE, and C. difficile colonization, and to define the functional aspects of keystone microbiota and mechanisms of protection against colonization/infection.

Patients will be recruited from both intensive care units (n=500) and stem cell transplant units (n=500) and will be followed until discharge from these units, or for a maximum of four weeks. In addition to stool, blood, and oral samples, enrolled patients will have clinical data collected by chart review to evaluate colonization/infection-related clinical status, microbiological laboratory information, exposure to antibiotics, and clinical outcomes. Positive clinical cultures taken during the course of hospitalization will also be collected for analysis.

Eligibility

Inclusion Criteria:

  • Admission to an intensive care unit or stem cell transplant unit (for allogeneic stem cell transplantation) within previous 24 hours

Exclusion Criteria:

  • <18 years of age
  • Pregnancy
  • History of inflammatory bowel disease (Crohn's disease, ulcerative colitis)
  • Gastrointestinal derivation (colostomy, ileostomy, etc.)

Study details
    Antimicrobial Drug Resistance
    Antibiotic Resistant Infection
    Clostridium Difficile
    Carbapenem-Resistant Enterobacteriaceae Infection
    Extended Spectrum Beta-Lactamase Producing Bacteria Infection
    Vancomycin Resistant Enterococci Infection
    Carbapenem Resistant Bacterial Infection
    Vancomycin-Resistant Enterococcal Infection

NCT06258551

The Methodist Hospital Research Institute

22 February 2024

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A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

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