Antibiotic Resistant Infection, Antimicrobial Drug Resistance, Carbapenem Resistant Bacterial Infection, Carbapenem-Resistant Enterobacteriaceae Infection, Clostridium Difficile, Extended Spectrum Beta-Lactamase Producing Bacteria Infection, Vancomycin-Resistant Enterococcal Infection, Vancomycin Resistant Enterococci Infection
Conditions
Brief summary
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).
Detailed 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.
Interventions
None listed
Sponsors
National Institute of Allergy and Infectious Diseases (NIAID)
M.D. Anderson Cancer Center
Baylor College of Medicine
University of Houston
William Marsh Rice University
The University of Texas Health Science Center, Houston
The Methodist Hospital Research Institute
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Impact of Colonization on Clinical Outcomes Using DOOR Analysis | 30 days | A desirability of outcome ranking (DOOR) algorithm will be used to analyze the impact of colonization by any target organism (CRE/ESBL-E, VRE, or C. difficile) on 30 day clinical outcomes. DOOR outcomes will be ranked as follows: 1) alive without infection, 2) alive with infection, or 3) dead. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Additional Clinical Predictors of Negative Outcomes | 30 days | Separate univariable logistic regression models will be used to evaluate associations between each individual component of the DOOR outcome (i.e., mortality and clinical infection) and the type of colonization as well as other independent predictors of mortality (e.g., neutropenia, hemodialysis, Pitt score, among others). Variables with p \< 0.10 in bivariate analysis will also be included in the logistic models to assess for independent associations with outcome. |
Countries
United States
Contacts
Primary ContactCesar A Arias, MD, PhD, Msc
Outcome results
None listed