Recruiting

Observational Study

Sponsor:

University of Chicago

Code:

NCT06822465

Conditions

Pseudomonas Aeruginosa

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

P. aeruginosa using in vitro and in vivo assays

Study Details

Brief summary:

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.

Conditions

Pseudomonas Aeruginosa

Study ID

NCT06822465

Start date

Dec 19, 2024

Status verified date

Jan, 2026

Completion date

Dec, 2029

Anticipated

Primary completion date

Dec, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

100 participants

Anticipated

Interventions and Outcome Measures

Arms

Critically Ill Patients

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

Interventions

P. aeruginosa using in vitro and in vivo assays

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 investigators also plan 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.

Primary outcome measure

  • In vitro pyocyanin screening assay to determine if a stool sample has any virulence inducing ability on laboratory strains of P. aeruginosa [ Time Frame: Through study completion, an average of 3 years ]
  • In vivo C. elegans lethality model to determine if liquid media culture "spiked" with stool sample filtrate will induce a lethal phenotype in laboratory strains of P. aeruginosa [ Time Frame: Through study completion, an average of 3 years ]
  • PCR array analysis of known P. aeruginosa virulence genes following exposure to stool sample filtrate deemed to be highly activating by the in vitro pyocyanin assay and in vivo C. elegans lethality model. [ Time Frame: Through study completion, an average of 3 years ]

Central Contacts and Locations

Central contacts

Locations

The University of Chicago

Recruiting

Hyde Park, Illinois, United States, 60637

Contacts

John Alverdy, MD FACS FSIS

773-834-5087

Leila Yazdanbakhsh, MD FACS FSIS

7738345087leila.yazdanbakhsh@bsd.uchicago.edu

Principal Investigator:

John Alverdy, MD FACS FSIS

More Information

Sponsor

University of Chicago

Last update posted

Feb 2, 2026

Last verified

Jan, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Chicago on 2026-02-02.