Dynamics of Colonization and Infection by Multidrug-Resistant Pathogens in Immunocompromised and Critically Ill Patients
DYNAMITE
2 other identifiers
observational
1,000
1 country
2
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 2020
Longer than P75 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 8, 2020
CompletedFirst Submitted
Initial submission to the registry
February 6, 2024
CompletedFirst Posted
Study publicly available on registry
February 14, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2026
February 14, 2024
February 1, 2024
5.5 years
February 6, 2024
February 6, 2024
Conditions
Outcome Measures
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.
30 days
Secondary Outcomes (1)
Additional Clinical Predictors of Negative Outcomes
30 days
Study Arms (2)
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)
Eligibility Criteria
Patients are recruited from the intensive care units and stem cell transplant units from two major metropolitan hospitals
You may qualify if:
- Admission to an intensive care unit or stem cell transplant unit (for allogeneic stem cell transplantation) within previous 24 hours
You may not qualify if:
- \<18 years of age
- Pregnancy
- History of inflammatory bowel disease (Crohn's disease, ulcerative colitis)
- Gastrointestinal derivation (colostomy, ileostomy, etc.)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- The Methodist Hospital Research Institutelead
- National Institute of Allergy and Infectious Diseases (NIAID)collaborator
- M.D. Anderson Cancer Centercollaborator
- Baylor College of Medicinecollaborator
- University of Houstoncollaborator
- William Marsh Rice Universitycollaborator
- The University of Texas Health Science Center, Houstoncollaborator
Study Sites (2)
Houston Methodist Hospital
Houston, Texas, 77030, United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
Related Publications (7)
Evans SR, Rubin D, Follmann D, Pennello G, Huskins WC, Powers JH, Schoenfeld D, Chuang-Stein C, Cosgrove SE, Fowler VG Jr, Lautenbach E, Chambers HF. Desirability of Outcome Ranking (DOOR) and Response Adjusted for Duration of Antibiotic Risk (RADAR). Clin Infect Dis. 2015 Sep 1;61(5):800-6. doi: 10.1093/cid/civ495. Epub 2015 Jun 25.
PMID: 26113652BACKGROUNDvan Duin D, Lok JJ, Earley M, Cober E, Richter SS, Perez F, Salata RA, Kalayjian RC, Watkins RR, Doi Y, Kaye KS, Fowler VG Jr, Paterson DL, Bonomo RA, Evans S; Antibacterial Resistance Leadership Group. Colistin Versus Ceftazidime-Avibactam in the Treatment of Infections Due to Carbapenem-Resistant Enterobacteriaceae. Clin Infect Dis. 2018 Jan 6;66(2):163-171. doi: 10.1093/cid/cix783.
PMID: 29020404BACKGROUNDTaur Y, Xavier JB, Lipuma L, Ubeda C, Goldberg J, Gobourne A, Lee YJ, Dubin KA, Socci ND, Viale A, Perales MA, Jenq RR, van den Brink MR, Pamer EG. Intestinal domination and the risk of bacteremia in patients undergoing allogeneic hematopoietic stem cell transplantation. Clin Infect Dis. 2012 Oct;55(7):905-14. doi: 10.1093/cid/cis580. Epub 2012 Jun 20.
PMID: 22718773BACKGROUNDSatlin MJ, Chavda KD, Baker TM, Chen L, Shashkina E, Soave R, Small CB, Jacobs SE, Shore TB, van Besien K, Westblade LF, Schuetz AN, Fowler VG Jr, Jenkins SG, Walsh TJ, Kreiswirth BN. Colonization With Levofloxacin-resistant Extended-spectrum beta-Lactamase-producing Enterobacteriaceae and Risk of Bacteremia in Hematopoietic Stem Cell Transplant Recipients. Clin Infect Dis. 2018 Nov 13;67(11):1720-1728. doi: 10.1093/cid/ciy363.
PMID: 29701766BACKGROUNDCaballero S, Carter R, Ke X, Susac B, Leiner IM, Kim GJ, Miller L, Ling L, Manova K, Pamer EG. Distinct but Spatially Overlapping Intestinal Niches for Vancomycin-Resistant Enterococcus faecium and Carbapenem-Resistant Klebsiella pneumoniae. PLoS Pathog. 2015 Sep 3;11(9):e1005132. doi: 10.1371/journal.ppat.1005132. eCollection 2015 Sep.
PMID: 26334306BACKGROUNDLee KH, Han SH, Yong D, Paik HC, Lee JG, Kim MS, Joo DJ, Choi JS, Kim SI, Kim YS, Park MS, Kim SY, Yoon YN, Kang S, Jeong SJ, Choi JY, Song YG, Kim JM. Acquisition of Carbapenemase-Producing Enterobacteriaceae in Solid Organ Transplantation Recipients. Transplant Proc. 2018 Dec;50(10):3748-3755. doi: 10.1016/j.transproceed.2018.01.058.
PMID: 30577266BACKGROUNDUlrich RJ, Santhosh K, Mogle JA, Young VB, Rao K. Is Clostridium difficile infection a risk factor for subsequent bloodstream infection? Anaerobe. 2017 Dec;48:27-33. doi: 10.1016/j.anaerobe.2017.06.020. Epub 2017 Jun 29.
PMID: 28669864BACKGROUND
Related Links
Study Officials
- PRINCIPAL INVESTIGATOR
Cesar A Arias, MD, PhD, Msc
The Methodist Hospital Research Institute
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor and Chief, Division of Infectious Diseases
Study Record Dates
First Submitted
February 6, 2024
First Posted
February 14, 2024
Study Start
December 8, 2020
Primary Completion (Estimated)
June 1, 2026
Study Completion (Estimated)
June 1, 2026
Last Updated
February 14, 2024
Record last verified: 2024-02
Data Sharing
- IPD Sharing
- Will share
- 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.
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.