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

The Methodist Hospital Research Institute (TMHRI)

Status: Enrolling

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

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT06258551

1P01AI152999-01 (U.S. NIH Grant/Contract)

PRO00035528

Details and patient eligibility

About

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).

Full 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.

Enrollment: 1,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.)

Trial design

1,000 participants in 2 patient groups

Intensive Care Unit

Description:

Patients admitted to an intensive care unit (No interventions administered)

Bone Marrow Transplant Unit

Description:

Patients admitted to a cancer treatment center for allogeneic stem cell transplantation (No interventions administered)