Health TrialsbyHealthPanel

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

ConditionsAntimicrobial Drug ResistanceAntibiotic Resistant InfectionClostridium DifficileCarbapenem-Resistant Enterobacteriaceae InfectionExtended Spectrum Beta-Lactamase Producing Bacteria InfectionVancomycin Resistant Enterococci InfectionCarbapenem Resistant Bacterial InfectionVancomycin-Resistant Enterococcal Infection
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorThe Methodist Hospital Research Institute

About this trial

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).

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

<18 years of age

Pregnancy

History of inflammatory bowel disease (Crohn's disease, ulcerative colitis)

Gastrointestinal derivation (colostomy, ileostomy, etc.)

Trial population

Patients are recruited from the intensive care units and stem cell transplant units from two major metropolitan hospitals

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

1,000 Participants
are grouped into 2 trial groups
Group A: Intensive Care Unit
Group B: Bone Marrow Transplant Unit

Trial outcomes

Primary outcomes

1

Impact of Colonization on Clinical Outcomes Using DOOR Analysis

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.

Time frame
30 days

Secondary outcomes

1

Additional Clinical Predictors of Negative Outcomes

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.

Time frame
30 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The Methodist Hospital Research Institute

Lead sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborator

M.D. Anderson Cancer Center

Collaborator

Baylor College of Medicine

Collaborator

University of Houston

Collaborator

William Marsh Rice University

Collaborator

The University of Texas Health Science Center, Houston

Collaborator

Source ClinicalTrials.gov
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