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Pathobiomes in Gut of Critically Ill Patients

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The University of Chicago

Status

Enrolling

Conditions

Pseudomonas Aeruginosa

Treatments

Other: P. aeruginosa using in vitro and in vivo assays

Study type

Observational

Funder types

Other
NIH

Identifiers

NCT06822465
16494B
5R01GM062344-23 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

Despite powerful antibiotics, 50% of the intestinal tracts of critically ill surgical patients are colonized by Pseudomonas aeruginosa, whose mere presence in this site increases mortality fourfold by mechanisms that remain unknown. Many patients who survive the initial surgical trauma still succumb to multi-organ failure and septicemia secondary to an invasive nosocomial infection. The sequelae of shock, hypoxia, and parental nutrition result in injury to the intestinal mucosa, changes in gut permeability, and failure of intestinal defense mechanisms. These conditions put patients at risk for infection and multiple organ failure secondary to the translocation of enteric bacteria, initiating a systemic release of inflammatory mediators-a process that has been termed gut-derived sepsis.

Intestinal P. aeruginosa senses host factors released during stress and responds by activating its virulence gene machinery. As such, the presence of a highly activating intestinal milieu serves to induce virulence in strains of P. aeruginosa and this correlates to the severity of a patient's illness. While the host-pathogen interaction is a dynamic process, the study expects that as a patient's illness worsens or resolves over time, the "virulence-activating" properties of their intestinal milieu will change accordingly. This study will conduct a prospective observational trial in a population of critically ill patients at the Universtiy of Chicago Medical Center. This trial will entail collecting and screening stool samples obtained from critically ill patients for their virulence inducing capabilities on laboratory strains of P. aeruginosa using in vitro and in vivo assays. The study also plans to isolate strains of intestinal P. aeruginosa from stool samples to determine the prevalence of intestinal P. aeruginosa in a population of critically ill patients.

Enrollment

100 estimated patients

Sex

All

Ages

18 to 85 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Any ethnicity
  • Age > 18 years and < 85 years

Exclusion criteria

  • A known history of HIV/AIDS
  • Active pregnancy
  • Are incarcerated will be excluded from the study.

Trial design

100 participants in 1 patient group

Critically Ill Patients
Description:
All patients admitted to the burn intensive care unit (BICU), surgical intensive care unit (SICU), and the medical intensive care unit (MICU) longer than 24 hours at University of Chicago Medical Center
Treatment:
Other: P. aeruginosa using in vitro and in vivo assays

Trial contacts and locations

1

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Central trial contact

John Alverdy, MD FACS FSIS; Leila Yazdanbakhsh, MSCI

Data sourced from clinicaltrials.gov

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