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Understanding Multidrug-Resistant Bacteria in Critically Ill Patients

This observational study aims to understand how different types of bacteria, especially those resistant to many antibiotics (like C. difficile, Carbapenem-Resistant Enterobacteriaceae, and Extended Spectrum Beta-Lactamase Producing Bacteria), change in your body during a hospital stay. Researchers want to see if these changes increase or decrease your risk of getting an infection. You could join if you are 18 or older and have been admitted to an intensive care unit or a stem cell transplant unit within the last 24 hours. The study will look at how colonization by these bacteria impacts your health outcomes over 30 days. The current recruitment status is unclear.

Study design
This is an observational study planning to enroll 1000 participants. It will follow patients in intensive care units and stem cell transplant units.
What's involved
You would provide stool samples (up to twice a week), blood draws (once a week), and oral swabs (once a week) for up to four weeks or until discharge.
Compensation
Not stated in the trial record.
Follow-up
The impact of colonization on clinical outcomes will be measured at 30 days.

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NCT06258551

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

UNKNOWN
Not specifiedAges 18+Observational
The Methodist Hospital Research Institute
~1,000 participants
Updated 2024-02-14 on ClinicalTrials.gov

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Impact of Colonization on Clinical Outcomes Using DOOR Analysis
Measured over 30 days

Conditions

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

Explore related trials

Carbapenem-Resistant Enterobacteriaceae InfectionClostridium difficile InfectionInfection caused by extended spectrum beta-lactamase producing bacteriaVancomycin-Resistant Enterococci Infection

Where it's being run

2 sites across 1 states
Texas2

Study leadership

  • Cesar A Arias, MD, PhD, Msc · PRINCIPAL_INVESTIGATOR · The Methodist Hospital Research Institute

Who to contact

Cesar A Arias, MD, PhD, Msc
[email protected]
346-238-4870
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

Exclusion

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

What this trial measures

  • Impact of Colonization on Clinical Outcomes Using DOOR Analysis30 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.