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

February 6, 2024 updated by: Cesar Arias, The Methodist Hospital Research Institute
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).

Study Overview

Status

Recruiting

Conditions

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.

Study Type

Observational

Enrollment (Estimated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
      • Houston, Texas, United States, 77030
        • Recruiting
        • The University of Texas Md Anderson Cancer Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

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

Description

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.)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intensive Care Unit
Patients admitted to an intensive care unit (No interventions administered)
Bone Marrow Transplant Unit
Patients admitted to a cancer treatment center for allogeneic stem cell transplantation (No interventions administered)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Impact of Colonization on Clinical Outcomes Using DOOR Analysis
Time Frame: 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.
30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Additional Clinical Predictors of Negative Outcomes
Time Frame: 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.
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Methodist Hospital Research Institute

Collaborators

M.D. Anderson Cancer Center
National Institute of Allergy and Infectious Diseases (NIAID)
The University of Texas Health Science Center, Houston
Baylor College of Medicine
University of Houston
William Marsh Rice University

Investigators

  • Principal Investigator: Cesar A Arias, MD, PhD, Msc, The Methodist Hospital Research Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 8, 2020

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 1, 2026

Study Registration Dates

First Submitted

February 6, 2024

First Submitted That Met QC Criteria

February 6, 2024

First Posted (Actual)

February 14, 2024

Study Record Updates

Last Update Posted (Actual)

February 14, 2024

Last Update Submitted That Met QC Criteria

February 6, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRO00035528
  • 1P01AI152999-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data generated by the DYNAMITE projects and Functional Genomics Core will be made available to the public through presentations at scientific meetings, peer-reviewed journal publications and articles, and/or direct sharing or deposit of data into publicly accessible databases. All banked bacterial specimens (both infecting and colonizing isolates) will be made available. Single bacterial whole genome sequencing data will be submitted to the Short Read Archive (SRA) at NCBI for unassembled data, as well as GenBank for assembled data.16S and shotgun metagenomic data will be submitted to the SRA following host sequence removal, and assembled 16S amplicons will be submitted to GenBank. Proteomic raw MS data will be submitted to the Proteomics Identifications (PRIDE) Archive. Metabolomics raw MS data will be submitted to the National Metabolomics Data Repository (NMDR). All custom bioinformatics pipelines, tools, and analytical scripts will be made available in a GitHub repository.

IPD Sharing Time Frame

Proteomic and metabolomic data will be uploaded to their respective platforms prior to any manuscript submission to peer-reviewed journals and keys to the data will be provided to reviewers. Publication of the data in these repositories, as well as genomic sequencing data and bacterial specimens, will be made publicly available upon publication of results.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Antibiotic Resistant Infection

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in United Kingdom

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe